Back to resultsStudy to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty
Primary Purpose
Abdominoplasty
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Botulinum Neurotoxin Serotype E
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Abdominoplasty focused on measuring pain, neurotoxin
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Huntington Ambulatory Surgery Center
- Lotus Clinical Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Arm Label
Placebo
Botulinum Neurotoxin Serotype E Dose 1
Botulinum Neurotoxin Serotype E Dose 2
Botulinum Neurotoxin Serotype E Dose 3
Arm Description
Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.
Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Outcomes
Primary Outcome Measures
Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Secondary Outcome Measures
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Participants Overall Assessment of Pain Using the NPRS After Discharge
The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)
The participant assessed their pain using the 11-point NPRS-A, after sitting up in the bed unassisted at an angle of approximately ≥ 45 degrees, swinging legs out, putting feet down, standing up, and walking approximately 10 feet, where: 0=no pain to 10=worst pain imaginable.
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories
The participant assessed their overall pain control in the past 24 hours using the PGA 4-point scale where: 0=poor, 1=fair, 2=good and 3=excellent.
Number of Doses of Rescue Medications Used
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03429556
Brief Title
Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty
Official Title
A Phase 2 Study to Evaluate Safety and Efficacy of EB-001 Intramuscular (IM) Injections in Reducing Musculoskeletal Pain in Subjects Undergoing Elective Abdominoplasty Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision to terminate early
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
July 10, 2018 (Actual)
Study Completion Date
July 10, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 undergoing abdominoplasty.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominoplasty
Keywords
pain, neurotoxin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
Arm Title
Botulinum Neurotoxin Serotype E Dose 1
Arm Type
Experimental
Arm Description
Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
Arm Title
Botulinum Neurotoxin Serotype E Dose 2
Arm Type
Experimental
Arm Description
Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery.
Arm Title
Botulinum Neurotoxin Serotype E Dose 3
Arm Type
Experimental
Arm Description
Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery.
Intervention Type
Biological
Intervention Name(s)
Botulinum Neurotoxin Serotype E
Other Intervention Name(s)
EB-001, BoNT/E
Intervention Description
Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) of Participant's Assessment of Pain Using the Numerical Pain Rating Scale (NPRS) at Rest Between 12 and 96 Hours Postsurgery (AUC12-96)
Description
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time Frame
Every 2 hours from 12 to 96 hours postsurgery
Secondary Outcome Measure Information:
Title
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery
Description
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time Frame
Every 2 hours from 0 to 96 hours postsurgery
Title
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)
Description
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time Frame
Every 2 hours from 0 to 72 hours postsurgery
Title
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)
Description
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time Frame
Every 2 hours from 0 to 48 hours postsurgery
Title
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)
Description
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time Frame
Every 2 hours from 0 to 24 hours postsurgery
Title
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)
Description
The participant assessed their current pain using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable. AUC was calculated using the standard trapezoidal rule.
Time Frame
Every 2 hours from 12 to 24 hours postsurgery
Title
Participants Overall Assessment of Pain Using the NPRS After Discharge
Description
The participant assessed their pain after discharge using the 11-point NPRS where: 0=no pain to 10=worst pain imaginable.
Time Frame
Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26
Title
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)
Description
The participant assessed their pain using the 11-point NPRS-A, after sitting up in the bed unassisted at an angle of approximately ≥ 45 degrees, swinging legs out, putting feet down, standing up, and walking approximately 10 feet, where: 0=no pain to 10=worst pain imaginable.
Time Frame
8, 16, 24, 30, 36, 42, 48, 54, 60, 66, 72.78.84, and 96 hours after surgery; Days 8, 15 and 29 after discharge
Title
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories
Description
The participant assessed their overall pain control in the past 24 hours using the PGA 4-point scale where: 0=poor, 1=fair, 2=good and 3=excellent.
Time Frame
Days 5, 8, 15 and 29
Title
Number of Doses of Rescue Medications Used
Time Frame
Up to 96 hours postsurgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan-En Lin
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Huntington Ambulatory Surgery Center
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Lotus Clinical Research, LLC
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty
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