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

May 1, 2009 updated by: Anesiva, Inc.

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jung-gu
      • Daegu, Jung-gu, Korea, Republic of, 700-721
        • Kyungpook National University Hospital
    • Kyunggido
      • Seoul, Kyunggido, Korea, Republic of, 463-707
        • Seoul National University Hospital
    • Kyungsangnamdo
      • Jinju, Kyungsangnamdo, Korea, Republic of, 660-720
        • Gyeongsang National University Hospital
    • Seocho-gu
      • Seoul, Seocho-gu, Korea, Republic of, 137-040
        • KangNam St. Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome 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
Time Frame: 28 Days
28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anesiva, Inc.

Investigators

  • Study Director: Shaun Comfort, MD, Anesiva, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 2, 2008

First Posted (Estimate)

May 6, 2008

Study Record Updates

Last Update Posted (Estimate)

May 4, 2009

Last Update Submitted That Met QC Criteria

May 1, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114-04P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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