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Nonsteroidal Anti-inflammatory Drug (NSAID)

Diclofenac Sodium Patch for Acute Pain (SUPPORT 2 Trial)

Phase 3
Waitlist Available
Research Sponsored by Cerimon Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial

Summary

The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium topical patch in reducing acute pain due to mild to moderate ankle sprains when applied to the painful area.

Eligible Conditions
  • Acute Pain
  • Ankle Sprain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2011 Phase 3 trial • 205 Patients • NCT01272934
3%
Infections and infestations
1%
Nervous system disorders
1%
Gastrointestinal disorders
1%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diclofenac Sodium Topical Gel 1%
Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Diclofenac Sodium PatchExperimental Treatment1 Intervention
Group II: Topical Placebo PatchPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diclofenac
FDA approved

Find a Location

Who is running the clinical trial?

PPD DEVELOPMENT, LPIndustry Sponsor
157 Previous Clinical Trials
35,388 Total Patients Enrolled
2 Trials studying Acute Pain
621 Patients Enrolled for Acute Pain
Cerimon PharmaceuticalsLead Sponsor
7 Previous Clinical Trials
1,373 Total Patients Enrolled
2 Trials studying Acute Pain
621 Patients Enrolled for Acute Pain
PPDIndustry Sponsor
161 Previous Clinical Trials
36,172 Total Patients Enrolled
2 Trials studying Acute Pain
621 Patients Enrolled for Acute Pain
~13 spots leftby Oct 2025
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