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

Phase 2TerminatedNCT00672568

Anesiva, Inc.24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Rotator Cuff Repair of the Shoulder

Interventions

4975 - Highly purified capsaicinDRUG

Solution, 0.5 mg, single dose, injection

4975 - Highly purified capsaicinDRUG

Solution, 0.75 mg, single dose, injection

4975 - Highly purified capsaicinDRUG

Solution, 0.1 mg, Single dose, injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (4)

Kyungpook National university Hospital

Daegu, Jung-gu, South Korea

Seoul National University Hospital

Seoul, Kyunggido, South Korea

Gyeongsang National University Hospital

Jinju, Kyungsangnamdo, South Korea

Kangnam St. Mary's Hospital

Seoul, Seocho-gu, South Korea

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

Time frame: 28 Days

Data from ClinicalTrials.gov

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