Status:
TERMINATED
Safety and Tolerability of 4975 in Patients Undergoing Arthroscopic Surgery to Repair the Rotator Cuff of the Shoulder
Lead Sponsor:
Anesiva, Inc.
Conditions:
Rotator Cuff Repair of the Shoulder
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 rep...
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 ...
Eligibility Criteria
Inclusion
- Key
- Male or female between the ages of 18 and 75 inclusive
- In overall good health and planning to undergo unilateral arthroscopic shoulder surgery to repair at least one rotator cuff tendon involving humeral attachment
- Willing and able to complete the study procedures, pain assessments, and medication diaries, and to communicate in Korean or English with study personnel
- Key
Exclusion
- Shoulder surgery requiring concomitant repair of biceps muscle or associated tendon(s)
- Planning to undergo shoulder surgery on both shoulders
- Use of disallowed pain medications prior to the surgery
- Female patients who are pregnant or lactating or who plan to get pregnant
- Diabetes mellitus with a known HbA1C\>9.5
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00672568
Start Date
July 1 2008
End Date
December 1 2008
Last Update
May 4 2009
Active Locations (4)
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1
Kyungpook National university Hospital
Daegu, Jung-gu, South Korea, 700-721
2
Seoul National University Hospital
Seoul, Kyunggido, South Korea, 463-707
3
Gyeongsang National University Hospital
Jinju, Kyungsangnamdo, South Korea, 660-720
4
Kangnam St. Mary's Hospital
Seoul, Seocho-gu, South Korea, 137-040