Page last updated: 2024-10-26

diclofenac and Hallux Valgus

diclofenac has been researched along with Hallux Valgus in 4 studies

Diclofenac: A non-steroidal anti-inflammatory agent (NSAID) with antipyretic and analgesic actions. It is primarily available as the sodium salt.
diclofenac : A monocarboxylic acid consisting of phenylacetic acid having a (2,6-dichlorophenyl)amino group at the 2-position.

Hallux Valgus: Lateral displacement of the great toe (HALLUX), producing deformity of the first METATARSOPHALANGEAL JOINT with callous, bursa, or BUNION formation over the bony prominence.

Research Excerpts

ExcerptRelevanceReference
"Lower-dose diclofenac submicron particle capsules provided effective analgesia in this phase 3 clinical study in patients with acute pain and are a potentially promising option for the treatment of patients with acute pain."5.17Lower-dose diclofenac submicron particle capsules provide early and sustained acute patient pain relief in a phase 3 study. ( Argoff, C; Daniels, S; Gibofsky, A; Jensen, S; Silberstein, S; Young, CL, 2013)
" Additional measures included NPRS scores at predefined times over 48 hours, the summed pain intensity difference over 48 hours (SPID48), the time-weighted sum of pain relief scores over the first 8 hours, the mean dosing interval (the time from dosing to the time rescue medication or the next dose of study medication was administered, whichever was less), the proportion of patients requiring rescue medication, and the onset of perceptible and meaningful pain relief (2-stopwatch method)."2.74Diclofenac potassium liquid-filled soft gelatin capsules in the management of patients with postbunionectomy pain: a Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted over 5 days. ( Boesing, SE; Diamond, E; Duckor, S; Gottlieb, I; Raymond, G; Riff, DS; Soulier, S, 2009)
"Rofecoxib 50 mg was significantly more effective than placebo on all measures of treatment of post-bunionectomy pain."2.71A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain. ( Bird, SR; Black, PM; Chang, DJ; Daniels, S; Desjardins, PJ; Fitzgerald, BJ; Petruschke, RA; Tershakovec, A, 2004)

Research

Studies (4)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (50.00)29.6817
2010's2 (50.00)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Gibofsky, A1
Silberstein, S1
Argoff, C1
Daniels, S2
Jensen, S1
Young, CL1
Riff, DS1
Duckor, S1
Gottlieb, I1
Diamond, E1
Soulier, S1
Raymond, G1
Boesing, SE2
Daniels, SE1
Baum, DR1
Clark, F1
Golf, MH1
McDonnell, ME1
Desjardins, PJ1
Black, PM1
Bird, SR1
Fitzgerald, BJ1
Petruschke, RA1
Tershakovec, A1
Chang, DJ1

Clinical Trials (4)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery[NCT00366444]Phase 3201 participants (Actual)Interventional2006-08-31Completed
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery[NCT00375934]Phase 3200 participants (Actual)Interventional2006-09-30Completed
Towards Predicting the Analgesic Response to Ibuprofen Following Third-molar Extraction[NCT03893175]Phase 186 participants (Actual)Interventional2019-05-10Completed
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery Pain[NCT00092378]Phase 3251 participants (Actual)Interventional2003-09-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy

Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain (NCT00366444)
Timeframe: Over 48 hours after bunionectomy

Interventionunits on a scale (Mean)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule2.5
Placebo5.6

Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1

(NCT00366444)
Timeframe: 8 hours post single dose

Interventionminutes (Median)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule70.2

Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1

(NCT00366444)
Timeframe: 8 hours post single dose

Interventionminutes (Median)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule26.0
Placebo22.2

Number of Patients Who Required Rescue Medication on Day 1

(NCT00366444)
Timeframe: Day 1

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule40
Placebo87

Number of Patients Who Required Rescue Medication on Day 2

(NCT00366444)
Timeframe: Day 2

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule22
Placebo64

Number of Patients Who Required Rescue Medication on Day 3

Day 3 data reflect the use of rescue medication only up to the time of discharge (NCT00366444)
Timeframe: Day 3

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule5
Placebo29

Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug

(NCT00366444)
Timeframe: 8 hours post single dose

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule62
Placebo40

Number of Patients With Meaningful Pain Relief on Day 1

Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. (NCT00366444)
Timeframe: 8 hours post single dose

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule58
Placebo35

Number of Patients With Perceptible Pain Relief on Day 1

Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. (NCT00366444)
Timeframe: 8 hours post single dose

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule84
Placebo69

Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug

(NCT00366444)
Timeframe: 8 hours post single dose

Interventionminutes (Median)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule60

Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug

Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score. (NCT00366444)
Timeframe: 8 hours post single dose

Interventionunits on a scale (Mean)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule8.2
Placebo2.6

Average Numeric Pain Rating Score (NPRS) Over 48 Hours After Bunionectomy

Pain intensity scores were measured using an 11-point numerical pain rating scale (NPRS) with 0=no pain to 10=worst possible pain (NCT00375934)
Timeframe: Over 48 hours after bunionectomy

Interventionunits on a scale (Mean)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule3.3
Placebo5.7

Median Time to Onset of Pain Relief in Patients With Meaningful Pain Relief on Day 1

(NCT00375934)
Timeframe: 8 hours post single dose

Interventionminutes (Median)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule90.6

Median Time to Onset of Pain Relief in Patients With Perceptible Pain Relief on Day 1

(NCT00375934)
Timeframe: 8 hours post single dose

Interventionminutes (Median)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule42.9
Placebo36.0

Number of Patients Who Required Rescue Medication on Day 1

(NCT00375934)
Timeframe: Day 1

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule53
Placebo93

Number of Patients Who Required Rescue Medication on Day 2

(NCT00375934)
Timeframe: Day 2

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule30
Placebo68

Number of Patients Who Required Rescue Medication on Day 3

Day 3 data reflect the use of rescue medication only up to the time of discharge. (NCT00375934)
Timeframe: Day 3

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule4
Placebo19

Number of Patients With at Least 30% Reduction in Pain Intensity After First Dose of Study Drug

(NCT00375934)
Timeframe: 8 hours post single dose

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule51
Placebo31

Number of Patients With Meaningful Pain Relief on Day 1

Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. (NCT00375934)
Timeframe: 8 hours post single dose

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule50
Placebo30

Number of Patients With Perceptible Pain Relief on Day 1

Times to onset of Perceptible and Meaningful Relief were determined using the double-stopwatch method. (NCT00375934)
Timeframe: 8 hours post single dose

Interventionparticipants (Number)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule72
Placebo63

Time to Onset of at Least 30% Reduction in Pain Intensity After First Dose of Study Drug

(NCT00375934)
Timeframe: 8 hours post single dose

Interventionminutes (Median)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule110
Placebo300

Total Pain Relief (TOTPAR) Scores 8 Hours Post Initial Dose of Study Drug

Pain relief was rated using a 5-point categorial scale (0=none, 1=a little, 2=some, 3=a lot, and 4=complete) at time of dose (time=0) and over 15 time points afterwards (10, 15, 20, 30, 45, and 60 minutes and at 1.5, 2, 2.5, 3, 4, 5, 6, 7, and 8 hours after the initial dose on Day 1 or until time of re-medication). A score of 0 across all time points would be the lowest (worst) and a score of 60 (4 X 15 time points) would be the highest (best) possible score. (NCT00375934)
Timeframe: 8 hourse post single dose

Interventionunits on a scale (Mean)
Zipsor (Diclofenac Potassium) Liquid Filled Capsule5.9
Placebo1.9

Trials

4 trials available for diclofenac and Hallux Valgus

ArticleYear
Lower-dose diclofenac submicron particle capsules provide early and sustained acute patient pain relief in a phase 3 study.
    Postgraduate medicine, 2013, Volume: 125, Issue:5

    Topics: Acute Pain; Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Bli

2013
Diclofenac potassium liquid-filled soft gelatin capsules in the management of patients with postbunionectomy pain: a Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted over 5 days.
    Clinical therapeutics, 2009, Volume: 31, Issue:10

    Topics: Acetaminophen; Adolescent; Adult; Aged; Analgesics, Non-Narcotic; Analgesics, Opioid; Anesthesia; An

2009
Diclofenac potassium liquid-filled soft gelatin capsules for the treatment of postbunionectomy pain.
    Current medical research and opinion, 2010, Volume: 26, Issue:10

    Topics: Adolescent; Adult; Aged; Anti-Inflammatory Agents, Non-Steroidal; Capsules; Diclofenac; Dose-Respons

2010
A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain.
    Current medical research and opinion, 2004, Volume: 20, Issue:10

    Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Metho

2004
A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain.
    Current medical research and opinion, 2004, Volume: 20, Issue:10

    Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Metho

2004
A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain.
    Current medical research and opinion, 2004, Volume: 20, Issue:10

    Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Metho

2004
A randomized controlled study comparing rofecoxib, diclofenac sodium, and placebo in post-bunionectomy pain.
    Current medical research and opinion, 2004, Volume: 20, Issue:10

    Topics: Administration, Oral; Adult; Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Double-Blind Metho

2004