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

NCT00672568 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2009-05-04

No results posted yet for this study

Summary

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

Conditions

  • Rotator Cuff Repair of the Shoulder

Interventions

DRUG

4975 - Highly purified capsaicin

Solution, 0.5 mg, single dose, injection

DRUG

4975 - Highly purified capsaicin

Solution, 0.75 mg, single dose, injection

DRUG

4975 - Highly purified capsaicin

Solution, 0.1 mg, Single dose, injection

DRUG

Placebo

Solution, single dose, injection

Sponsors & Collaborators

  • Anesiva, Inc.

    lead INDUSTRY

Principal Investigators

  • Shaun Comfort, MD · Anesiva, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2008-10-31
Completion
2008-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00672568 on ClinicalTrials.gov