A Phase 3 interventional study of Diclofenac Sodium Patch and Matching Placebo Patch in Acute Pain, sponsored by Cerimon Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 17 Years to 75 Years. Per ClinicalTrials.gov, last updated 2010-01-28.
Sponsored by Cerimon Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of the 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 wrist sprain, strain or contusion when applied to the painful area.
This randomized, double-blind, placebo-controlled, parallel group study will be conducted in patients with a mild to moderate wrist sprain, strain or contusion.
Eligible patients will be randomized (in a 1:1 ratio) to receive double-blind treatment to either the diclofenac topical patch or a matching placebo patch to be applied once daily for 7 days. Patients will return to the clinic for assessments on Day 3 and Day 7; a follow-up assessment will be conducted on Day 14. Patients will complete an electronic diary in which assessments including pain intensity, pain relief and functional disability will be recorded twice daily. Ratings of the quality of sleep will also be recorded in the diary each morning, and the use of study treatment and rescue medication will be recorded in the diary each day.
1,073 studies on the registry are indexed under Acute Pain; 166 are open to participants now.
This study's enrollment of 214 is above the median of 86 across 902 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Cerimon Pharmaceuticals is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Drug: Diclofenac Sodium Patch
Drug: Matching Placebo Patch
Topical 1% diclofenac sodium patch, applied once daily for 7 days
Matching placebo patch, containing identical constituents to the active drug arm except for diclofenac sodium; applied once daily for 7 days
Change in average pain during daily activity
Time frame: Day 3
Change in average pain during daily activity
Time frame: Day 7
The record gives a start of Feb 2009, a primary completion of Jul 2009 and a completion of Sep 2009. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diclofenac
Cerimon Pharmaceuticals