Rotator Cuff Repair of the Shoulder
Conditions
Keywords
Rotator cuff, Shoulder, Arthroscopic shoulder surgery
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.
Interventions
DRUG4975 - Highly purified capsaicin
Solution, 0.5 mg, single dose, injection
DRUGPlacebo
Solution, single dose, injection
Sponsors
Anesiva, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key 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 Key
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery | 28 Days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Outcome results
None listed