rofecoxib and Low Back Ache studies

Research Excerpts

Excerpt	Relevance	Reference
"We recently reported the efficacy of rofecoxib in two randomized controlled trials in chronic low back pain (CLBP)."	9.11	Onset of pain relief with rofecoxib in chronic low back pain: results of two four-week, randomized, placebo-controlled trials. ( Katz, N; Krupa, D; Reicin, A; Rodgers, DB, 2004)
"Two replicate, 4-week, randomized, double-blind, placebo-controlled, trials of rofecoxib 25 and 50 mg versus placebo for chronic low back pain."	9.10	Efficacy and safety of rofecoxib in patients with chronic low back pain: results from two 4-week, randomized, placebo-controlled, parallel-group, double-blind trials. ( Borenstein, D; Bozalis Rodgers, D; Coleman, S; Fisher, C; Gertz, BJ; Gimbel, J; Ju, WD; Katz, N; Krupa, DA; Nabizadeh, S; Sperling, RS, 2003)
"The case of a 59-year-old healthy woman is described, who developed an extreme sinus bradycardia (30/min) with chest pain and acute right heart failure associated with gastrointestinal symptoms and elevation of the liver enzymes while simultaneously taking tizanidine (Sirdalud), diclofenac (Voltaren), and rofecoxib (Vioxx)."	7.73	[Extreme sinus bradycardia (30/min) with acute right heart failure under tizanidine (Sirdalud). Possible pharmacological interaction with rofecoxib (Vioxx)]. ( Bertoli, R; Caduff Janosa, P; Cerny, A; Kick, A; Moschovitis, G, 2005)
"We recently reported the efficacy of rofecoxib in two randomized controlled trials in chronic low back pain (CLBP)."	5.11	Onset of pain relief with rofecoxib in chronic low back pain: results of two four-week, randomized, placebo-controlled trials. ( Katz, N; Krupa, D; Reicin, A; Rodgers, DB, 2004)
"This randomized, double-dummy, double-blind pilot study of acutely exacerbated low back pain was aimed to inform a definitive comparison between Doloteffin, a proprietary extract of Harpagophytum, and rofecoxib, a selective inhibitor of cyclo-oxygenase-2 (COX-2)."	5.10	A randomized double-blind pilot study comparing Doloteffin and Vioxx in the treatment of low back pain. ( Black, A; Chrubasik, S; Model, A; Pollak, S, 2003)
"Two replicate, 4-week, randomized, double-blind, placebo-controlled, trials of rofecoxib 25 and 50 mg versus placebo for chronic low back pain."	5.10	Efficacy and safety of rofecoxib in patients with chronic low back pain: results from two 4-week, randomized, placebo-controlled, parallel-group, double-blind trials. ( Borenstein, D; Bozalis Rodgers, D; Coleman, S; Fisher, C; Gertz, BJ; Gimbel, J; Ju, WD; Katz, N; Krupa, DA; Nabizadeh, S; Sperling, RS, 2003)
" Exploratory studies indicate that these herbal antirheumatics were not inferior to the selective COX-2 inhibitor rofecoxib when treating acute exacerbations of chronic low back pain."	4.81	[Pain management with herbal antirheumatic drugs]. ( Chrubasik, S; Pollak, S, 2002)
"To complete a year's follow-up on patients from a 6-week double-blind pilot comparison between 44 Doloteffin patients and 44 rofecoxib patients being treated for acute exacerbations of chronic low back pain."	3.73	A 1-year follow-up after a pilot study with Doloteffin for low back pain. ( Black, A; Chrubasik, S; Conradt, C; Künzel, O; Thanner, J, 2005)
"The case of a 59-year-old healthy woman is described, who developed an extreme sinus bradycardia (30/min) with chest pain and acute right heart failure associated with gastrointestinal symptoms and elevation of the liver enzymes while simultaneously taking tizanidine (Sirdalud), diclofenac (Voltaren), and rofecoxib (Vioxx)."	3.73	[Extreme sinus bradycardia (30/min) with acute right heart failure under tizanidine (Sirdalud). Possible pharmacological interaction with rofecoxib (Vioxx)]. ( Bertoli, R; Caduff Janosa, P; Cerny, A; Kick, A; Moschovitis, G, 2005)
"Treatment with rofecoxib was about 40% more expensive than that with Assalix."	2.70	Treatment of low back pain with a herbal or synthetic anti-rheumatic: a randomized controlled study. Willow bark extract for low back pain. ( Black, A; Chrubasik, S; Conradt, C; Künzel, O; Model, A, 2001)
" Comparisons were made between patients taking rofecoxib and those taking either placebo, naproxen (an NSAID with near-complete inhibition of platelet function throughout its dosing interval), or another nonselective NSAIDs used in the development program (diclofenac, ibuprofen, and nabumetone)."	2.41	Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. ( Barr, E; Gertz, BJ; Konstam, MA; Reicin, A; Shapiro, D; Sperling, RS; Weir, MR, 2001)
"Rofecoxib is a selective cyclooxygenase-2 inhibitor that has been approved for the treatment of osteoarthritis and management of acute pain."	1.33	Ischemic colitis associated with rofecoxib. ( Feltri, M; Meucci, G; Minoli, G; Radaelli, F; Spinzi, G; Terruzzi, V, 2005)

Research

Studies (13)

Authors

Clinical Trials (4)

Trial Overview

Trial Outcomes

Hamilton Depression Rating Scale (HAM-D-24)

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	12 (92.31)	29.6817
2010's	1 (7.69)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Oltean, H	1
Robbins, C	1
van Tulder, MW	1
Berman, BM	1
Bombardier, C	2
Gagnier, JJ	2
Chrubasik, S	4
Model, A	2
Black, A	3
Pollak, S	2
Giles, LG	1
Muller, R	1
Katz, N	2
Ju, WD	1
Krupa, DA	1
Sperling, RS	2
Bozalis Rodgers, D	1
Gertz, BJ	2
Gimbel, J	1
Coleman, S	1
Fisher, C	1
Nabizadeh, S	1
Borenstein, D	1
Rodgers, DB	1
Krupa, D	1
Reicin, A	2
Künzel, O	2
Thanner, J	1
Conradt, C	2
Kick, A	1
Bertoli, R	1
Moschovitis, G	1
Caduff Janosa, P	1
Cerny, A	1
Radaelli, F	1
Feltri, M	1
Meucci, G	1
Spinzi, G	1
Terruzzi, V	1
Minoli, G	1
van Tulder, M	1
Berman, B	1
Konstam, MA	1
Weir, MR	1
Shapiro, D	1
Barr, E	1
Freitas, J	1
Farricha, V	1
Nascimento, I	1
Borralho, P	1
Paramés, A	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Evaluation of the Impact of the HL Natural, Inc. Tension Relief Product on the Reduction of Symptoms in Adults Who Suffer From Mild to Moderate Tension Headaches[NCT04091555]		117 participants (Actual)	Interventional	2019-10-16	Completed
Trigger Point Dry Needling vs Trigger Point Dry Needling With Intramuscular Electrical Stimulation for the Treatment of Sub-acute and Chronic Low Back Pain in a Military Population: A Randomized Crossover Design[NCT03539588]		30 participants (Actual)	Interventional	2017-04-12	Completed
Changes in Pressure Pain Thresholds and Basal Electromyographic Activities Following Spinal Mechanical Manipulation in Asymptomatic Subjects[NCT01469533]		30 participants (Actual)	Interventional	2011-07-31	Completed
Double-blind, Placebo-controlled Study of the Safety and Efficacy of Eszopiclone in the Treatment of Insomnia in Patients With Chronic Low Back Pain[NCT00365976]	Phase 4	58 participants (Actual)	Interventional	2006-08-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The Hamilton Depression Scale - 24 Items (HAM-D-24) measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 76. The higher the score, the more severe. (NCT00365976)
Timeframe: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4

Insomnia Severity Index (ISI)

Intervention	units on a scale (Mean)
	prenaprosyn Baseline	postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	6.45	6.38	4.54	4.14	2.62
Placebo	7.10	6.57	5.53	5.07	6.21

The ISI is a seven-item self-report questionnaire that provides a global measure of insomnia severity based on difficulty falling or staying asleep, satisfaction with sleep, or degree of impairment with daytime functioning. The total score ranges from 0-28: 0-7 (no clinical insomnia), 8-14 (subthreshold insomnia), 15-21 (insomnia of moderate severity), and 22-28 (severe insomnia). (NCT00365976)
Timeframe: Prenaprosyn Baseline, Postnaprosyn Baseline, Week 1, Week 2 week 4

Mean Sleep Onset Latency (SOL)

Mean Subjective Sleep Diary Derived Total Sleep Time (TST)

Intervention	units on a scale (Mean)
	Prenaprosyn Baseline	Postnaprosyn baseline	Week 1	Week 2	Week 4
Eszopiclone	18.85	18.00	11.28	10.61	8.38
Placebo	20.26	16.78	12.85	12.74	13.75

Intervention	minutes (Mean)
	Postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	38.28	22.36	17.50	15.28
Placebo	34.11	27.00	23.10	19.91

Nightly total sleep time was averaged from diary entries. (NCT00365976)
Timeframe: Postnaprosyn baseline, Week 1, week 2, week 4

Number of Awakenings

Patient Global Impression of Pain Ratings

Intervention	Minutes (Mean)
	postnaprosyn baseline	week 1	week 2	Week 4
Eszopiclone	316.96	403.47	421.97	411.97
Placebo	380.45	375.56	382.11	388.96

Intervention	awakenings (Mean)
	Postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	2.29	1.31	1.35	1.33
Placebo	2.08	1.98	2.13	2.34

Pain ratings included a global impression of pain rating (PGI) (1-5 rating with 1 being little pain and 5 is worst pain) (NCT00365976)
Timeframe: postnaprosyn Baseline, Week 1, Week 2 week 4

Roland Morris Low Back Pain Inventory (RMLBPI)

Intervention	units on a scale (Mean)
	postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	4.02	3.54	3.30	3.08
Placebo	3.90	3.82	4.01	3.80

"The Roland-Morris Low Back Pain Disability Questionnaire (RMLBPDQ) is a 24-item instrument that assesses the extent to which activities of daily living are affected by LBP. It is composed of 24 yes-no items assessing potential disabilities.~Scores range from 0 (no disability) to 24 (severe disability)." (NCT00365976)
Timeframe: prenaprosyn baseline, postnaprosyn Baseline, Week 1, Week 2, week 4

Sleep Quality Ratings

Intervention	units on a scale (Mean)
	prenaprosyn Baseline	postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	12.27	9.97	9.10	7.63	6.59
Placebo	11.33	10.30	9.05	9.32	7.94

Sleep quality ratings are based on a 1-10 Likert scale. Low scores represent poorer sleep quality and higher scores represent better quality sleep (NCT00365976)
Timeframe: Postnaprosyn Baseline, Week 1, Week 2 week 4

Visual Analog Scale Pain Ratings (VAS)

Intervention	units on a scale (Mean)
	Postnaprosyn Baseline	Week 1	Week 2	Week 4
Eszopiclone	4.52	5.99	6.18	6.38
Placebo	4.44	4.90	5.33	5.29

Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain (NCT00365976)
Timeframe: Postnaprosyn baseline, Week 1, Week 2, Week 4

Article	Year
Herbal medicine for low-back pain. The Cochrane database of systematic reviews, 2014, Dec-23, Issue:12 Topics: Acute Pain; Adult; Benzyl Alcohols; Capsicum; Chronic Pain; Cyclooxygenase 2 Inhibitors; Glucosides;	2014
Herbal medicine for low back pain. The Cochrane database of systematic reviews, 2006, Apr-19, Issue:2 Topics: Adult; Benzyl Alcohols; Capsicum; Cyclooxygenase 2 Inhibitors; Glucosides; Harpagophytum; Herbal Med	2006
Cardiovascular thrombotic events in controlled, clinical trials of rofecoxib. Circulation, 2001, Nov-06, Volume: 104, Issue:19 Topics: Aged; Alzheimer Disease; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Cardiovascu	2001
[Pain management with herbal antirheumatic drugs]. Wiener medizinische Wochenschrift (1946), 2002, Volume: 152, Issue:7-8 Topics: Anti-Inflammatory Agents, Non-Steroidal; Clinical Trials as Topic; Humans; Lactones; Low Back Pain;	2002

Article	Year
A randomized double-blind pilot study comparing Doloteffin and Vioxx in the treatment of low back pain. Rheumatology (Oxford, England), 2003, Volume: 42, Issue:1 Topics: Acute Disease; Aged; Antirheumatic Agents; Cyclooxygenase 2; Double-Blind Method; Drug Costs; Enzyme	2003
Chronic spinal pain: a randomized clinical trial comparing medication, acupuncture, and spinal manipulation. Spine, 2003, Jul-15, Volume: 28, Issue:14 Topics: Acupuncture Therapy; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Chronic Disease; Double-Bli	2003
Chronic spinal pain: a randomized clinical trial comparing medication, acupuncture, and spinal manipulation. Spine, 2003, Jul-15, Volume: 28, Issue:14 Topics: Acupuncture Therapy; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Chronic Disease; Double-Bli	2003
Chronic spinal pain: a randomized clinical trial comparing medication, acupuncture, and spinal manipulation. Spine, 2003, Jul-15, Volume: 28, Issue:14 Topics: Acupuncture Therapy; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Chronic Disease; Double-Bli	2003
Chronic spinal pain: a randomized clinical trial comparing medication, acupuncture, and spinal manipulation. Spine, 2003, Jul-15, Volume: 28, Issue:14 Topics: Acupuncture Therapy; Anti-Inflammatory Agents, Non-Steroidal; Celecoxib; Chronic Disease; Double-Bli	2003
Efficacy and safety of rofecoxib in patients with chronic low back pain: results from two 4-week, randomized, placebo-controlled, parallel-group, double-blind trials. Spine, 2003, May-01, Volume: 28, Issue:9 Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Chronic Disease; Cyclooxygenase In	2003
Onset of pain relief with rofecoxib in chronic low back pain: results of two four-week, randomized, placebo-controlled trials. Current medical research and opinion, 2004, Volume: 20, Issue:5 Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Disabil	2004
Treatment of low back pain with a herbal or synthetic anti-rheumatic: a randomized controlled study. Willow bark extract for low back pain. Rheumatology (Oxford, England), 2001, Volume: 40, Issue:12 Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase	2001

Article	Year
A 1-year follow-up after a pilot study with Doloteffin for low back pain. Phytomedicine : international journal of phytotherapy and phytopharmacology, 2005, Volume: 12, Issue:1-2 Topics: Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Female; Follow-Up Studies; Glycosides;	2005
[Extreme sinus bradycardia (30/min) with acute right heart failure under tizanidine (Sirdalud). Possible pharmacological interaction with rofecoxib (Vioxx)]. Medizinische Klinik (Munich, Germany : 1983), 2005, Apr-15, Volume: 100, Issue:4 Topics: Acute Disease; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Bradycardia; Clonidine; Cyclooxy	2005
Ischemic colitis associated with rofecoxib. Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver, 2005, Volume: 37, Issue:5 Topics: Abdominal Pain; Colitis, Ischemic; Colon; Cyclooxygenase Inhibitors; Female; Gastrointestinal Hemorr	2005
Rofecoxib: a possible cause of acute colitis. Journal of clinical gastroenterology, 2002, Volume: 34, Issue:4 Topics: Acute Disease; Colitis; Cyclooxygenase Inhibitors; Female; Gastrointestinal Hemorrhage; Humans; Lact	2002

rofecoxib and Low Back Ache