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

This study has been terminated.
(Study has been halted after completing Stage 1, for corporate reasons. No future patients will be enrolled or treated.)
Sponsor:
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00672568
First received: May 2, 2008
Last updated: May 1, 2009
Last verified: May 2009
  Purpose

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 Intervention Phase
Rotator Cuff Repair of the Shoulder
Drug: 4975 - Highly purified capsaicin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Anesiva, Inc.:

Primary Outcome Measures:
  • Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery [ Time Frame: 28 Days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: July 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
4975
Drug: 4975 - Highly purified capsaicin
Solution, 0.5 mg, single dose, injection
Other Name: Adlea
Experimental: 2
4975
Drug: 4975 - Highly purified capsaicin
Solution, 0.75 mg, single dose, injection
Other Name: Adlea
Experimental: 3
4975
Drug: 4975 - Highly purified capsaicin
Solution, 0.1 mg, Single dose, injection
Other Name: Adlea
Placebo Comparator: 4
Placebo
Drug: Placebo
Solution, single dose, injection
Other Name: Placebo

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00672568

Locations
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.
Investigators
Study Director: Shaun Comfort, MD Anesiva, Inc.
  More Information

No publications provided

Responsible Party: Shaun Comfort, MD, Anesiva, Inc.
ClinicalTrials.gov Identifier: NCT00672568     History of Changes
Other Study ID Numbers: 114-04P
Study First Received: May 2, 2008
Last Updated: May 1, 2009
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014