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

Rotator Cuff Repair of the Shoulder Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00672568
• Other study ID #: 114-04P
• Status: Terminated
• Phase: Phase 2
• First received: May 2, 2008
• Last updated: May 1, 2009
• Start date: July 2008
• Est. completion date: December 2008

Study information

• Verified date: May 2009
• Source: Anesiva, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Rotator Cuff Repair of the Shoulder

Intervention

Drug:
• 4975 - Highly purified capsaicin
Solution, 0.5 mg, single dose, injection
• 4975 - Highly purified capsaicin
Solution, 0.75 mg, single dose, injection
• 4975 - Highly purified capsaicin
Solution, 0.1 mg, Single dose, injection
• Placebo
Solution, single dose, injection

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National university Hospital	Daegu	Jung-gu
Korea, Republic of	Gyeongsang National University Hospital	Jinju	Kyungsangnamdo
Korea, Republic of	Kangnam St. Mary's Hospital	Seoul	Seocho-gu
Korea, Republic of	Seoul National University Hospital	Seoul	Kyunggido

Sponsors (1)

Lead Sponsor	Collaborator
Anesiva, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery		28 Days	No
Secondary	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	Yes