Study Stopped
Study has been halted after completing Stage 1, for corporate reasons. No future patients will be enrolled or treated.
Safety and Tolerability of 4975 in Patients Undergoing Arthroscopic Surgery to Repair the Rotator Cuff of the Shoulder
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
1 other identifier
interventional
24
1 country
4
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jul 2008
Shorter than P25 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 2, 2008
CompletedFirst Posted
Study publicly available on registry
May 6, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMay 4, 2009
May 1, 2009
3 months
May 2, 2008
May 1, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery
28 Days
Secondary Outcomes (1)
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
28 Days
Study Arms (4)
1
EXPERIMENTAL4975
2
EXPERIMENTAL4975
3
EXPERIMENTAL4975
4
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anesiva, Inc.lead
Study Sites (4)
Kyungpook National university Hospital
Daegu, Jung-gu, 700-721, South Korea
Seoul National University Hospital
Seoul, Kyunggido, 463-707, South Korea
Gyeongsang National University Hospital
Jinju, Kyungsangnamdo, 660-720, South Korea
Kangnam St. Mary's Hospital
Seoul, Seocho-gu, 137-040, South Korea
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Shaun Comfort, MD
Anesiva, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 2, 2008
First Posted
May 6, 2008
Study Start
July 1, 2008
Primary Completion
October 1, 2008
Study Completion
December 1, 2008
Last Updated
May 4, 2009
Record last verified: 2009-05