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

Information source: Anesiva, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rotator Cuff Repair of the Shoulder

Intervention: 4975 - Highly purified capsaicin (Drug); 4975 - Highly purified capsaicin (Drug); 4975 - Highly purified capsaicin (Drug); Placebo (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Anesiva, Inc.

Official(s) and/or principal investigator(s):
Shaun Comfort, MD, Study Director, Affiliation: Anesiva, Inc.

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

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery

Secondary outcome: 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

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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Kyungpook National university Hospital, Daegu, Jung-gu 700-721, Korea, Republic of

Seoul National University Hospital, Seoul, Kyunggido 463-707, Korea, Republic of

Gyeongsang National University Hospital, Jinju, Kyungsangnamdo 660-720, Korea, Republic of

Kangnam St. Mary's Hospital, Seoul, Seocho-gu 137-040, Korea, Republic of

Additional Information

Starting date: July 2008
Last updated: May 1, 2009

Page last updated: August 20, 2015

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