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:
Anesiva, Inc.
Information provided by:
Anesiva, Inc.
ClinicalTrials.gov Identifier:
NCT00672568
First received: May 2, 2008
Last updated: May 1, 2009
Last verified: May 2009
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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
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 June 17, 2013