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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Rotator Cuff Repair of the Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

4975

Group Type EXPERIMENTAL

4975 - Highly purified capsaicin

Intervention Type DRUG

Solution, 0.5 mg, single dose, injection

2

4975

Group Type EXPERIMENTAL

4975 - Highly purified capsaicin

Intervention Type DRUG

Solution, 0.75 mg, single dose, injection

3

4975

Group Type EXPERIMENTAL

4975 - Highly purified capsaicin

Intervention Type DRUG

Solution, 0.1 mg, Single dose, injection

4

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Solution, single dose, injection

Interventions

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4975 - Highly purified capsaicin

Solution, 0.5 mg, single dose, injection

Intervention Type DRUG

4975 - Highly purified capsaicin

Solution, 0.75 mg, single dose, injection

Intervention Type DRUG

4975 - Highly purified capsaicin

Solution, 0.1 mg, Single dose, injection

Intervention Type DRUG

Placebo

Solution, single dose, injection

Intervention Type DRUG

Other Intervention Names

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Adlea Adlea Adlea

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No