Status:
TERMINATED
Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty
Lead Sponsor:
Allergan
Conditions:
Abdominoplasty
Eligibility:
All Genders
23-55 years
Phase:
PHASE2
Brief Summary
To determine the safety and efficacy of single intra-operative treatment of Botulinum Neurotoxin Serotype E (EB-001) intramuscular (IM) injections into the Rectus Abdominus (RA) in participants underg...
Eligibility Criteria
Inclusion
- Men or women 23 to 55 years of age, inclusive
- Scheduled to undergo elective abdominoplasty surgery with full length plication from xyphoid to pubis, and removal of skin/fat flap under general anesthesia (endotracheal or otherwise) without liposuction
- American Society of Anesthesiologist (ASA) Physical Class 1-2.
Exclusion
- History of prior major abdominal surgery as judged by the investigator
- Pre-existing lung disease that could impact participant safety in the opinion of the investigator
- Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)
- At high risk of deep vein thrombosis as judged by the investigators determined by a Caprini score of 3 or higher
- Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender or below 2.5 Liters (L) of absolute volume
- Pulse oximetry below 95%
- Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
- Reported use of any botulinum toxin within 3 months prior to the date of surgery
- Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery
- Aminoglycoside intake within 48 hours prior to or during surgery
- Participants on anti-depressant or anti-psychotic medications
- Reported pain score of 2 or more at screening on the 11-point scale numerical pain rating scale-administered after an activity (NPRS-A) following an activity after and walking approximately 10 feet.
Key Trial Info
Start Date :
May 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03429556
Start Date
May 8 2018
End Date
July 10 2018
Last Update
August 5 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Huntington Ambulatory Surgery Center
Pasadena, California, United States, 91105
2
Lotus Clinical Research, LLC
Pasadena, California, United States, 91105