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
Overview
- Phase
- Phase 2
- Intervention
- 4975 - Highly purified capsaicin
- Conditions
- Rotator Cuff Repair of the Shoulder
- Sponsor
- Anesiva, Inc.
- Enrollment
- 24
- Locations
- 4
- Primary Endpoint
- Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery
- Status
- Terminated
- Last Updated
- 17 years ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
1
4975
Intervention: 4975 - Highly purified capsaicin
2
4975
Intervention: 4975 - Highly purified capsaicin
3
4975
Intervention: 4975 - Highly purified capsaicin
4
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery
Time Frame: 28 Days
Secondary Outcomes
- Mean overall daily pain and worst daily pain. Pain intensity with physical therapy. Safety outcomes include ECG, vital signs, adverse drug reactions, and wound exams(28 Days)