NCT00672568

Safety and Tolerability of 4975 in Patients Undergoing Arthroscopic Surgery to Repair the Rotator Cuff of the Shoulder

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Two-Stage Exploratory Study to Evaluate Safety, Tolerability, Efficacy, and Pharmacokinetics of Intraoperative Subacromial Injection With 4975 in Patients Undergoing Arthroscopic Rotator Cuff Repair of the Shoulder

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Anesiva, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability and explore the efficacy of a single intraoperative injection of 4975 in patients undergoing arthroscopic surgery for rotator cuff repair of the shoulder

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled, two-stage exploratory study in patients undergoing arthroscopic rotator cuff repair surgery. Stage 1) Patients will be randomized to receive either 4975 or placebo. The dose of 4975 will be escalated in a protocolized manner based on safety and tolerability. Stage 2) Patients will be randomized in a 1:1 ratio to receive either the selected dose of 4975 or placebo. All patients will be observed in the hospital for at least two days following surgery for safety, tolerability, and efficacy assessments. In addition there will be two planned follow-up visits after hospital discharge.

Conditions

• Rotator Cuff Repair of the Shoulder

Interventions

Type	Name	Description
DRUG	4975 - Highly purified capsaicin	Solution, 0.5 mg, single dose, injection
DRUG	4975 - Highly purified capsaicin	Solution, 0.75 mg, single dose, injection
DRUG	4975 - Highly purified capsaicin	Solution, 0.1 mg, Single dose, injection
DRUG	Placebo	Solution, single dose, injection

Timeline

• Start date: 2008-07-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2008-05-06
• Last updated: 2009-05-04

Locations

4 sites across 1 country: South Korea