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NCT00640939
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 Tendonitis or Bursitis
Phase 2/Phase 3 trial testing diclofenac sodium in Rotator Cuff Tendonitis in 308 participants. Completed in 1 June 2008.
1 April 2008
Quick facts
| Lead sponsor | Cerimon Pharmaceuticals |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 308 |
| Start date | 1 December 2007 |
| Primary completion | 1 April 2008 |
| Estimated completion | 1 June 2008 |
| Sites | 1 location across United States |
Drugs / interventions tested
- diclofenac sodium (Diclofenac Sodium) — full drug profile →
- Matching Placebo — full drug profile →
Conditions studied
- Rotator Cuff Tendonitis — all drugs for Rotator Cuff Tendonitis →
- Bicipital Tendonitis — all drugs for Bicipital Tendonitis →
- Subdeltoid Bursitis of the Shoulder — all drugs for Subdeltoid Bursitis of the Shoulder →
- Subacromial Bursitis of the Shoulder — all drugs for Subacromial Bursitis of the Shoulder →
Sponsor
Cerimon Pharmaceuticals
Who can join
Adults 18 to 75, any sex, with Rotator Cuff Tendonitis or Bicipital Tendonitis. 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 tendonitis or bursitis of the shoulder, elbow, or wrist.
Time frame: 14 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 one of the following: the affected shoulder, elbow, or wrist. The secondary purpose of this study is to assess the safety and tolerability of the diclofenac patch on the subject's skin, in the location being studied.
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 NCT00640939
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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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 NCT00640939 (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: 5 August 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/NCT00640939.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing