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NCT00640705
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of a Diclofenac Sodium Patch for the Topical Treatment of Pain Due to Mild to Moderate Ankle Sprain.
Phase 2/Phase 3 trial testing diclofenac sodium in Ankle Sprain in 170 participants. Terminated before completion.
1 July 2008
Quick facts
| Lead sponsor | Cerimon Pharmaceuticals |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 170 |
| Start date | 1 January 2008 |
| Primary completion | 1 July 2008 |
| Estimated completion | 1 October 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- diclofenac sodium (Diclofenac Sodium) — full drug profile →
- Matching placebo patch
Conditions studied
- Ankle Sprain — all drugs for Ankle Sprain →
Sponsor
Cerimon Pharmaceuticals
Who can join
Adults 18 to 75, any sex, with Ankle Sprain. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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Assess the efficacy of diclofenac in subjects with mild to moderate ankle sprain.
Time frame: 7 days
Sponsor's own description
The primary purpose of this study is to assess the effectiveness of once daily application of a diclofenac sodium patch to the skin near or over the painful area. In this study, the location being studied will be either the left or right ankle. The secondary purpose of this study is to assess the safety and tolerability of a diclofenac patch on the skin.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Topical NSAIDs for acute musculoskeletal pain in adults.
Derry S, Moore RA, Gaskell H, McIntyre M, et al · · 2015 · cited 74× · PMID 26068955 · DOI 10.1002/14651858.cd007402.pub3
Verify or expand the search:
- PubMed search for NCT00640705
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of diclofenac sodium
Trials testing the same drug.
- NCT06937853 — Effect of Genetic Polymorphisms on Response to Preoperative NSAIDs in Endodontic Postoperative Pain Management · NA · recruiting
Other recruiting trials for Ankle Sprain
Currently open trials in the same condition.
- NCT07190599 — NMES With PNF for Ankle Sprain Rehabilitation · NA · recruiting
- NCT07154433 — A Study on Reducing Opioid Use After Minimally Invasive Ankle Surgery · NA · recruiting
- NCT07200271 — Surgical Management of Lateral Ankle Instability: Modified Broström-Gould Versus Arthroscopic Allograft Reconstruction o · NA · recruiting
- NCT07025733 — Semiconductor Embedded Socks for Ankle Sprains · NA · recruiting
- NCT06623929 — Topical Treatments for Ankle Sprains · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00640705 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cerimon Pharmaceuticals
- Last refreshed: 3 September 2008
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00640705.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing