Viewing Study NCT00640705


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Study NCT ID: NCT00640705
Status: TERMINATED
Last Update Posted: 2008-09-04
First Post: 2008-03-18
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Diclofenac Patch for Treatment of Mild to Moderate Ankle Sprain
Sponsor: Cerimon Pharmaceuticals
Organization:

Study Overview

Official Title: 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.
Status: TERMINATED
Status Verified Date: 2008-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Sponsor decision
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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.
Detailed Description: Cerimon Pharmaceuticals is investigating a topical patch formulation of diclofenac sodium containing 15 mg of diclofenac sodium for the local treatment of acute musculoskeletal pain.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: