Clinical trial NCT00672568: Safety and Tolerability of 4975 in Patients Undergoing Arthroscopic Surgery to Repair the Rotator Cuff of the Shoulder
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rotator Cuff Repair of the Shoulder
Keywords: Rotator cuff, Shoulder, Arthroscopic shoulder surgery
Lead sponsor: Anesiva, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-06
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Pain intensity using a standard 11-point numerical rating system (NRS), which will be assessed at predefined times following surgery
timeFrame: 28 Days
Secondary outcomes:
measure: 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
timeFrame: 28 Days
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National university Hospital
state: Jung-gu
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Kyunggido
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Kyungsangnamdo
city: Seoul
country: Korea, Republic of
facility: Kangnam St. Mary's Hospital
state: Seocho-gu
Study officials:
affiliation: Anesiva, Inc.
name: Shaun Comfort, MD
role: STUDY_DIRECTOR
References: