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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00672568
Recruitment Status : Terminated (Study has been halted after completing Stage 1, for corporate reasons. No future patients will be enrolled or treated.)
First Posted : May 6, 2008
Last Update Posted : May 4, 2009
Information provided by:
Anesiva, Inc.

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

Condition or disease Intervention/treatment Phase
Rotator Cuff Repair of the Shoulder Drug: 4975 - Highly purified capsaicin Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: 1
Drug: 4975 - Highly purified capsaicin
Solution, 0.5 mg, single dose, injection
Other Name: Adlea
Experimental: 2
Drug: 4975 - Highly purified capsaicin
Solution, 0.75 mg, single dose, injection
Other Name: Adlea
Experimental: 3
Drug: 4975 - Highly purified capsaicin
Solution, 0.1 mg, Single dose, injection
Other Name: Adlea
Placebo Comparator: 4
Drug: Placebo
Solution, single dose, injection

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00672568

Korea, Republic of
Kyungpook National university Hospital
Daegu, Jung-gu, Korea, Republic of, 700-721
Seoul National University Hospital
Seoul, Kyunggido, Korea, Republic of, 463-707
Gyeongsang National University Hospital
Jinju, Kyungsangnamdo, Korea, Republic of, 660-720
Kangnam St. Mary's Hospital
Seoul, Seocho-gu, Korea, Republic of, 137-040
Sponsors and Collaborators
Anesiva, Inc.
Study Director: Shaun Comfort, MD Anesiva, Inc.

Additional Information:
Responsible Party: Shaun Comfort, MD, Anesiva, Inc. Identifier: NCT00672568     History of Changes
Other Study ID Numbers: 114-04P
First Posted: May 6, 2008    Key Record Dates
Last Update Posted: May 4, 2009
Last Verified: May 2009

Keywords provided by Anesiva, Inc.:
Rotator cuff, Shoulder, Arthroscopic shoulder surgery

Additional relevant MeSH terms:
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs