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

Anesiva

Status and phase: Terminated; Phase 2

Conditions: Rotator Cuff Repair of the Shoulder

Treatments: Drug: Placebo; Drug: 4975 - Highly purified capsaicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00672568

114-04P

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

4975

Treatment:

Drug: 4975 - Highly purified capsaicin

Drug: 4975 - Highly purified capsaicin

Drug: 4975 - Highly purified capsaicin

2

Experimental group

Description:

4975

Treatment:

Drug: 4975 - Highly purified capsaicin

Drug: 4975 - Highly purified capsaicin

Drug: 4975 - Highly purified capsaicin

3

Experimental group

Description:

4975

Treatment:

Drug: 4975 - Highly purified capsaicin

Drug: 4975 - Highly purified capsaicin

Drug: 4975 - Highly purified capsaicin

4

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo