fentanyl and Chronic Pain

fentanyl has been researched along with Chronic Pain in 75 studies

Fentanyl: A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)
fentanyl : A monocarboxylic acid amide resulting from the formal condensation of the aryl amino group of N-phenyl-1-(2-phenylethyl)piperidin-4-amine with propanoic acid.

Chronic Pain: Aching sensation that persists for more than a few months. It may or may not be associated with trauma or disease, and may persist after the initial injury has healed. Its localization, character, and timing are more vague than with acute pain.

Research

Studies (75)

Authors

Clinical Trials (9)

Trial Overview

Trial Outcomes

Average Pain Intensity Before the Start of Tapentadol Treatment

"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale (NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine." (NCT00986258)
Timeframe: Baseline

Change in Average Pain Intensity After 12 Weeks of Tapentadol Prolonged Release Treatment.

"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity." (NCT00986258)
Timeframe: Baseline; End of Week 12 (12 weeks)

Change in Average Pain Intensity After 6 Weeks of Tapentadol Prolonged Release Treatment.

"For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated no pain and a score of 10 indicated pain as bad as you can imagine. The value indicates the change from the baseline value on the 0 to 10 scale. A negative value indicates a reduction in pain intensity from the baseline average pain intensity." (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 weeks)

Mean Equipotency Ratio of Tapentadol Compared to Buprenorphine

Tapentadol was compared to Buprenorphine with Buprenorphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Buprenorphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Buprenorphine. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Mean Equipotency Ratio of Tapentadol Compared to Fentanyl

Tapentadol was compared to Transdermal Fentanyl with Fentanyl set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Transdermal Fentanyl was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Fentanyl. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Mean Equipotency Ratio of Tapentadol Compared to Hydromorphone

Tapentadol was compared to Hydromorphone with Hydromorphone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Hydromorphone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Hydromorphone. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Mean Equipotency Ratio of Tapentadol Compared to Morphine

Tapentadol was compared to Morphine with Morphine set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Morphine was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Morphine. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Mean Equipotency Ratio of Tapentadol Compared to Oxycodone

Tapentadol was compared to Oxycodone with Oxycodone set to 1. The average total daily dose of Tapentadol at which a pain score equivalent or below to the pain score at the end of observation period under Oxycodone was reached was documented as the equipotent or equianalgesic dose to the total daily dose of the previously used Oxycodone. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Number of Participants That Responded to Treatment

Participants were considered responders if they reported the same or less average pain intensity over a 3 day period (NRS-3) after 6 weeks of tapentadol prolonged release treatment compared to their previous analgesic treatment (over a 3 day period on the Numeric Rating Scale) at Week 6 compared with Week-1. (NCT00986258)
Timeframe: 6 weeks

painDETECT Assessment at Baseline

"The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear." (NCT00986258)
Timeframe: Baseline

painDETECT Assessment for Participants After 12 Weeks of Tapentadol Prolonged Release Treatment

"The baseline painDETECT score was reassessed at the end of Week 12.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear." (NCT00986258)
Timeframe: End of Week 12

painDETECT Assessment for Participants After 6 Weeks of Tapentadol Prolonged Release Treatment

"The baseline painDETECT score was reassessed at the end of Week 6.~It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being negative (no neuropathic pain component). Value between 19 and 38 as being positive (presence of neuropathic component). Values from 13 to 18 are scored as being unclear." (NCT00986258)
Timeframe: End of Week 6

Change in the Health Survey Scores Form (SF-36)

The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline. (NCT00986258)
Timeframe: Baseline; End of Week 12 (12 Weeks)

Change in the Health Survey Scores Form (SF-36)

The Scores Form 36 (SF-36) includes several brief questions on 8 aspects, (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean (average) for each neuropathic symptom in a sub-scale.~The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)." (NCT00986258)
Timeframe: End of Week 12

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in a sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)." (NCT00986258)
Timeframe: End of Week 6

Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score

"All participants were requested to complete the NPSI (Neuropathic Pain Symptom Inventory) questionnaire at this visit. Each participant rated their own neuropathic pain symptoms by answering ten questions relating to neuropathic symptoms on an 11-point scale 0 (not present) to 10 (worst imaginable) for each question. The higher the score for a question (sub-scale) the more bothersome the symptom is for the participant.~Results are reported as the mean for each neuropathic symptom in the sub-scale. The mean score is reported on a scale of 0 (not present in the group) to 1 (symptom has the maximum imaginable intensity for the whole group)." (NCT00986258)
Timeframe: Baseline

Patient Global Impression of Change

In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. (NCT00986258)
Timeframe: Baseline; End of Week 12 (12 Weeks)

Patient Global Impression of Change

In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse. (NCT00986258)
Timeframe: Baseline; End of Week 6 (6 Weeks)

Clinician Global Impression of Change (CGIC) at Visit 8- 2 Months After Open Label Treatment

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. Here it was assessed 2 months after the start of the open-label extension period.~The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)." (NCT00813488)
Timeframe: Two months after start of open-label extension period

Clinician Global Impression of Change (CGIC) at Visit 9- 3 Months After Open Label Treatment

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination), which correspond to 1, 2, or 3 months after the start of the open-label extension period." (NCT00813488)
Timeframe: 3 months after start of open-label extension period

Clinician Global Impression of Change (CGIC)Endpoint

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination)." (NCT00813488)
Timeframe: End of open-label extension period

Clinician Global Impression of Change at Visit 7- 1 Month After Open Label Treatment

"The CGIC is a standardized tool that measures the change in a patient's overall status rating since the start of the open-label extension period, in the opinion of the clinician.~The 7-point scale includes very much worse=-3, much worse=-2, minimally worse=-1,no change=0, minimally improved=+1, much improved=+2, and very much improved=+3. The CGIC was completed by the clinicians at visits 7, 8, and 9 (or early termination) which correspond to 1, 2, or 3 months after the start of the open-label extension period." (NCT00813488)
Timeframe: One month after start of open-label extension

Pain Intensity Difference (PID) at 10 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID10 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 10 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 10 minutes after dosing

Pain Intensity Difference (PID) at 15 Minutes Post-treatment (PID15)

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 15 minutes after dosing

Pain Intensity Difference (PID) at 30 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 30 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 30 minutes after dosing

Pain Intensity Difference (PID) at 45 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 45 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 45 minutes after dosing

Pain Intensity Difference (PID) at 5 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 5 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 5 minutes after dosing

Pain Intensity Difference (PID) at 60 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI score from the episode baseline (immediately prior to study drug administration) and 60 minutes after the administration of the study drug. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: Immediately pre-dose and 60 minutes after dosing

Pain Relief (PR) Score at 5 Minutes Post-treatment

The PR score 5 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 5 minutes after treatment

Pain Relief Score at 10 Minutes Post-treatment

The PR score 10 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 10 minutes after treatment with study drug

Pain Relief Score at 15 Minutes Post-treatment

The PR score 15 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 15 minutes after treatment with study drug

Pain Relief Score at 30 Minutes Post-treatment

The PR score 30 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 30 minutes after treatment with study drug

Pain Relief Score at 45 Minutes Post-treatment

The PR score 45 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 45 minutes after treatment with study drug

Pain Relief Score at 60 Minutes Post-treatment

The PR score 60 minutes after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). (NCT00813488)
Timeframe: 60 minutes after treatment with study drug

Patient Global Impression of Change (PGIC) at Visit 7- 1 Month After Open Label Treatment

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. This was assessed 1 month after start of the open-label extension period. (NCT00813488)
Timeframe: One month after start of open-label treatment

Patient Global Impression of Change (PGIC) at Visit 8- 2 Months After Open Label Treatment

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 2 months after the start of the open-label extension period. (NCT00813488)
Timeframe: 2 months after start of open-label extension period

Patient Global Impression of Change (PGIC) at Visit 9- 3 Months After Open Label Treatment

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed 3 months after the start of the open-label extension period. (NCT00813488)
Timeframe: 3 months after start of open-label extension period

Patient Global Impression of Change (PGIC) Endpoint

The PGIC is a standardized self-report tool that measures the change in a patient's overall status rating since the start of the open-label extension period. The 7-point scale includes very much worse= -3, much worse= -2, minimally worse= -1, no change=0, minimally improved= +1, much improved= +2, and very much improved= +3. Here it was assessed at the conclusion of the open-label extension period. (NCT00813488)
Timeframe: At conclusion of open-label extension period

Percent Total Pain Relief at 60 Minutes Posttreatment (%TOTPAR)

The PR score at set intervals after the administration of study drug during the double-blind treatment phase was recorded in the patient's diary. The PR scale is a 5-point categorical scale of 0-4 (0=none, 1=slight, 2=moderate, 3=a lot, 4=complete). The maximum TOTPAR score that could be achieved at 60 minutes is equal to 16; thus, %TOTPAR at 60 minutes is (TOTPAR60 /16) x 100.The % TOTPAR achieved 60 minutes after the administration of study drug was calculated during the double-blind treatment phase. (NCT00813488)
Timeframe: From 5 minutes through 60 minutes after study drug treatment

Percentage Change in Pain Intensity Difference (% PID) at 10 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID10 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 10 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. This was assessed during the double-blind treatment period. (NCT00813488)
Timeframe: Immediately before treatment and 10 minutes after treatment.

Percentage Change in Pain Intensity Difference (% PID) at 15 Minutes Post-treatment

Pain intensity (PI) scores were assessed during the double-blind treatment period on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain. The PID15 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 15 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Baseline (immediately pre-dose) and 15 minutes after dosing

Percentage Change in Pain Intensity Difference (% PID) at 30 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID30 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 30 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Pre-dose and 30 minutes after dosing

Percentage Change in Pain Intensity Difference (% PID) at 45 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID45 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 45 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Immediately pre-dose and 45 minutes after dosing

Percentage Change in Pain Intensity Difference (% PID) at 5 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID5 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 5 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Immediately pre-dose and 5 minutes after dosing

Percentage Change in Pain Intensity Difference (% PID) at 60 Minutes Post-treatment

Pain intensity (PI) scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine after each episode of breakthrough pain during the double-blind treatment period. The PID60 is the difference between the PI scores from the episode baseline (immediately prior to study drug administration)and 60 minutes after the administration of the study drug. The difference is calculated and assessed as a percentage of the baseline pain intensity score. (NCT00813488)
Timeframe: Immediately pre-dose and 60 minutes after dosing

Sum of Pain Intensity Difference at 30 Minutes Post-treatment (SPID30)

PI scores were assessed on an 11-point numerical rating scale from 0 = no pain to 10 = pain as bad as you can imagine. SPID30 were derived from PID values. The SPID30 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 30 minutes,after the administration of study drug. SPID30 = (⅓ x PID5) + (⅓ x PID10) + (⅓ x PID15) + PID30. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry. (NCT00813488)
Timeframe: From 5 minutes after dosing through 30 minutes after dosing

Sum of Pain Intensity Difference at 60 Minutes Post-treatment (SPID60)

"PI scores were assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine during the double-blind treatment period. The SPID60 was derived from PID values. The SPID60 scores during the double-blind treatment phase were calculated as the time- weighted sum of the PID scores from 5 through 60 minutes,after the administration of the study drug.~SPID60 = SPID30 + PID45 + PID60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry." (NCT00813488)
Timeframe: From 5 minutes after dosing through 60 minutes after dosing

Time to Any Pain Relief (APR) by Treatment - <= 5 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 5 minutes or less was compared. (NCT00813488)
Timeframe: From time study drug was taken until 5 minutes after treatment

Time to Any Pain Relief (APR) by Treatment <=10 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 10 minutes or less was compared. (NCT00813488)
Timeframe: From study drug treatment until 10 minutes after treatment

Time to Any Pain Relief (APR) by Treatment <=15 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 15 minutes or less was compared. (NCT00813488)
Timeframe: From study drug administration to 15 minutes after treatment

Time to Any Pain Relief (APR) by Treatment <=30 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 30 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration till 30 minutes after treatment

Time to Any Pain Relief (APR) by Treatment <=45 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 45 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug treatment until 45 minutes after treatment

Time to Any Pain Relief (APR) by Treatment <=60 Minutes

Time to APR (subjective perception of any reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No APR-rescue medication used, and No APR-no rescue medication used)the number of episodes which time to APR fell in that category was compared. Number of episodes where APR was achieved in 60 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug treatment until 60 minutes after treatment

Time to Meaningful Pain Relief (MPR) by Treatment - <= 5 Minutes

Time to MPR (subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point up to 60 minutes during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. (NCT00813488)
Timeframe: From time study drug was taken until 5 minutes after treatment

Time to Meaningful Pain Relief (MPR) by Treatment <=10 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 10 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug treatment until 10 minutes after treatment

Time to Meaningful Pain Relief (MPR) by Treatment <=15 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 15 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration until 15 minutes after treatment

Time to Meaningful Pain Relief (MPR) by Treatment <=30 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 30 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration until 30 minutes after treatment

Time to Meaningful Pain Relief (MPR) by Treatment <=45 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 45 minutes or less was compared. (NCT00813488)
Timeframe: From study drug administration until 45 minutes after treatment

Time to Meaningful Pain Relief (MPR) by Treatment <=60 Minutes

Time to MPR(subjective perception of meaningful reduction in pain intensity) was measured by stopwatch and by scheduled questions at each time point during double-blind treatment period. No pain relief was defined as: patient indicated no pain relief experienced, rescue medication was used,or missing data. For each category (<5, <10, <15, <30, <45, <60 minutes, No MPR-rescue medication used, and No MPR-no rescue medication used)the number of episodes which time to MPR fell in that category was compared. Number of episodes in which MPR was achieved in 60 minutes or less was compared. (NCT00813488)
Timeframe: Time of study drug administration until 60 minutes after treatment

Total Pain Relief at 60 Minutes (TOTPAR60)

"The mean TOTPAR at 60 minutes will be calculated for each episode as the weighted sum of Pain Relief (PR) scores (5-point Likert scale, 0 = none to 4 = complete) at each assessment of PR (during the double-blind treatment period) until 60 minutes after study drug administration, as follows:~TOTPAR60 =(⅓ x PR5)+ (⅓ x PR10) +(⅓ x PR15)+ PR30 + PR45 + PR60. Least squared mean was from an analysis of variance (ANOVA) with treatment as randomized, phase, and sequence as fixed factors and patient as a random factor using compound symmetry." (NCT00813488)
Timeframe: From 5 minutes to 60 minutes after dosing

Use of Standard Rescue Medication

Any use of standard rescue medication after the administration of study drug for relief of Breakthrough Pain (BTP) during the double-blind treatment phase was recorded in the patient's diary. The number of breakthrough pain episodes for which study drug treatment was administered and which required rescue medication use was recorded. (NCT00813488)
Timeframe: Throughout the double-blind treatment period

Breakthrough Pain Preference Questionnaire

The BTP preference questionnaire is a questionnaire used to measure patients' preference for FBT or immediate-release oxycodone for management of BTP. The question is used to determine a patient's preference between the study drugs given in the 2 double-blind treatment periods. The patient was asked to select 1 of the following: 1, a preference for study drug used in the 1st double-blind treatment period; 2, a preference for study drug used in the 2nd double-blind treatment period; or 3, no preference. (NCT00813488)
Timeframe: At Visit 6 ( up to 42 days depending upon how long it takes the patient to manage their BTP) after completion of both double-blind treatment periods.

Medication Performance Assessment 30 Minutes Post-treatment

"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 30 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded." (NCT00813488)
Timeframe: 30 minutes post-treatment

Medication Performance Assessment 60 Minutes Post-treatment

"The medication performance assessment assessed study drug performance on a 5-point categorical scale of 0-4 (0=poor, 1=fair,2=good, 3=very good, 4=excellent) 60 minutes after administration of study drug during the double-blind treatment periods and for the first 5 BTP episodes after each visit during the open-label extension period were recorded in the patient's paper diary. Patients were asked How well did your study medication perform in controlling this breakthrough pain episode? The number of episodes rated for each category were recorded." (NCT00813488)
Timeframe: 60 minutes post-treatment

Change in Pill Swallowing Difficulty Score

"Pill swallowing difficulty will be measured via a 0-10 scale with 0 being no trouble at all and 10 being the greatest difficulty possible. Responses will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study. Baseline covers current opioid medication, and week 6 covers Xtampza ER.

Effect of Xtampza ER Conversion on Pain Intensity in the Last 24 Hours

"Percent change in pain intensity (in the last 24 hours) from baseline to the end of the study averaged over the last 7 days before clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

Effect of Xtampza ER Conversion on Pain Intensity in the Last 7 Days

"Percent change in pain intensity (in the past 7 days) from baseline to the end of the study at clinic visit 4 (week 6). Pain Intensity is measured on a 0-10 scale, with 0 meaning no pain and 10 meaning the worst pain imaginable. As decreases in pain intensity are a sign of improvement, percent change in pain intensity is calculated as -(end of study - baseline)/baseline score." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

Opioid Medication Satisfaction

"Opioid medication satisfaction will be measured via a 0-10 scale with 0 being not satisfied at all and 10 being completely satisfied. Responses will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study. Recorded baseline for current opioid medication and in week 6 for Xtampza ER.

Patient Global Impression of Change (PGIC)

The subject's impression of the impact of the treatment on their pain and function will be measured with a 7-item scale (-3 = very much worse, -2 = much worse, -1 = minimally worse, 0 = no change, 1 = minimally improved, 2 = much improved, 3 = very much improved). Responses will be summarized as individual mean scores at clinic visit 4 (week 6). (NCT03588806)
Timeframe: Recorded in week 6.

Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference

"The Pain Interference questions (#25-28) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being Not at all and 5 being Very much. Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Pain Interference T-Scores will be summarized as the change from baseline scores to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

PROMIS Physical Function

"The Physical Function questions (#1-4) from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 5 being Without any difficulty and 1 being Unable to do. Responses will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. Physical Function T-Scores will be summarized as change from baseline score to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

PROMIS Depression, Anxiety, Satisfaction With Social Roles, and Sleep Disturbance

"The Depression (#9-12), Anxiety (#5-8), Satisfaction with Social Roles (#21-24), and Sleep Disturbance (#17-20) questions from the PROMIS-29 Adult Profile v2.0. Questions are measured on a 5-point scale with 1 being Never and 5 being Always. Responses for each section will be summed and converted to T-Scores using the Assessment Center PROMIS Scoring Service (www.assessmentcenter.net), which rescales the raw score to a standardized T-Score with a population mean of 50 and standard deviation of 10. These T-Scores will be summarized as change from baseline scores to the end of the study at clinic visit 4 (week 6)." (NCT03588806)
Timeframe: Measured at baseline and at the end of the 6-week study

Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy

Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted. (NCT01008553)
Timeframe: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)

Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period

The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain. (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period

The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain. (NCT01008553)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Doses of Rescue Treatment Per Day - Double-Blind Period

If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Doses of Rescue Treatment Per Day - Titration Period

If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. (NCT01008553)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period

"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied." (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period

"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied." (NCT01008553)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period

Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period

Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. (NCT01008553)
Timeframe: Day 29 or final evaluation (Titration period)

Pain Visual Analog Scale (VAS) Score - Double-Blind Period

"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported." (NCT01008553)
Timeframe: Day 27-29 (Titration period) and Day 83-85 (double-blind period)

Pain Visual Analog Scale (VAS) Score - Titration Period

"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported." (NCT01008553)
Timeframe: Day 12-14 (Screening period) and Day 27-29 (Titration period)

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Double-Blind Period

The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. (NCT01008553)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) Score - Titration Period

The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. (NCT01008553)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Time From the Initial Day of Application in Double-Blind Period to Withdrawal Because of Insufficient Analgesic Efficacy

Time from start of double-blind (researchers and participants were unaware of the treatment) period to withdrawal because of insufficient analgesic efficacy based on any of the pre-defined discontinuation criteria was noted. (NCT01008618)
Timeframe: Day 1 up to Day 85 (double-blind period) and Day 92 (discontinuation of the study)

Brief Pain Inventory Short Form (BPI-sf) Score - Double-Blind Period

The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain. (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Brief Pain Inventory Short Form (BPI-sf) Score - Titration Period

The BPI-sf total score is an average of the pain interference score (mean value for the nine BPI-sf questions [questions inquiring about the extent of interference with activities by pain, where the extent is ranked from 0 (does not interfere) to 10 (completely interferes)]) and pain subscale score (mean value for the scores for BPI-sf questions 3, 4, 5 and 6 [questions inquiring about the extent of pain, where the extent is ranked from 0 (no pain) to 10 (pain as bad as you can imagine)]). Total score ranges from 0 to 10 with higher values indicating more pain. (NCT01008618)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Doses of Rescue Treatment Per Day - Double-Blind Period

If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported. (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Doses of Rescue Treatment Per Day - Titration Period

If a breakthrough pain occurred or the analgesic efficacy became insufficient, a fast-acting oral morphine was administered. At such instances, one-time dose of the rescue treatment was administered as per the pre-defined criteria. During hospitalization, Investigator, Sub-investigator or Study Collaborator recorded in the medical record and during the out-patient period, the participants were instructed to describe the name of rescue treatment, date and time of treatment, and one-time dose in the participant's diary. The mean number of treatments per day at each assessment time was reported. (NCT01008618)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Participants Evaluated as Per Participant's Overall Assessment - Double-Blind Period

"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied." (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Participants Evaluated as Per Participant's Overall Assessment - Titration Period

"The participant assessed his/her satisfaction with the therapeutic efficacy by the following 5 grades: Extremely satisfied, Satisfied, Neither satisfied nor dissatisfied, Dissatisfied and Dissatisfied very much. The results were reported as Category 1 = At least Neither satisfied nor dissatisfied, which included participants with general evaluation of Extremely satisfied to Neither satisfied nor dissatisfied, and Category 2 = At least Satisfied, which included participants with general evaluation of Extremely satisfied to Satisfied." (NCT01008618)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

Number of Participants Evaluated as Per Physician's Overall Assessment - Double-Blind Period

Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Number of Participants Evaluated as Per Physician's Overall Assessment - Titration Period

Physician's global assessment of therapeutic efficacy (effectiveness) of the study drug was measured on a 2-point scale where 1 = effective and 2 = not effective. (NCT01008618)
Timeframe: Day 29 or final evaluation (Titration period)

Pain Visual Analog Scale (VAS) Score - Double-Blind Period

"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of titration period and during 3 days before the end of double-blind period was reported." (NCT01008618)
Timeframe: Day 27-29 (Titration period) and Day 83-85 (double-blind period)

Pain Visual Analog Scale (VAS) Score - Titration Period

"The intensity of average pain (degree of pain) felt by the participants in daily living throughout the day on a 100-millimeter (mm) VAS scale by drawing a slash. The left margin (0 mm) was considered No pain at all, and the right margin (100 mm) was considered Severer pain than this is inconceivable. The length (mm) from the left margin to the slash is measured. Mean VAS score during 3 days before the end of Screening period and during 3 days before the end of titration period was reported." (NCT01008618)
Timeframe: Day 12-14 (Screening period) and Day 27-29 (Titration period)

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Double-Blind Period:

The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. (NCT01008618)
Timeframe: Day 1 and 85 or final evaluation (double-blind period)

Short-Form 36-Item Health Survey Version 2.0 (SF-36v2) - Titration Period

The SF-36v2 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. (NCT01008618)
Timeframe: Day 1 and 29 or final evaluation (Titration period)

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