Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty

Abdominoplasty Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03429556
• Other study ID #: EB001-ABD201
• Status: Terminated
• Phase: Phase 2
• Start date: May 8, 2018
• Est. completion date: July 10, 2018

Study information

• Verified date: August 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: July 10, 2018
• Est. primary completion date: July 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Men or women 23 to 55 years of age, inclusive

2. 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

3. American Society of Anesthesiologist (ASA) Physical Class 1-2.

Exclusion Criteria:

1. History of prior major abdominal surgery as judged by the investigator

2. Pre-existing lung disease that could impact participant safety in the opinion of the investigator

3. Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)

4. At high risk of deep vein thrombosis as judged by the investigators determined by a Caprini score of 3 or higher

5. 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

6. Pulse oximetry below 95%

7. Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of = 32

8. Reported use of any botulinum toxin within 3 months prior to the date of surgery

9. Use of long acting opioids within 3 days or any opioid medication within 24 hours prior to surgery

10. Aminoglycoside intake within 48 hours prior to or during surgery

11. Participants on anti-depressant or anti-psychotic medications

12. 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.

Related Conditions & MeSH terms

• Abdominoplasty
• Musculoskeletal Pain

Intervention

Biological:
• Botulinum Neurotoxin Serotype E
Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.

Drug:
• Placebo
Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.

Locations

Country	Name	City	State
United States	Huntington Ambulatory Surgery Center	Pasadena	California
United States	Lotus Clinical Research, LLC	Pasadena	California

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Every 2 hours from 12 to 96 hours postsurgery
Secondary	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.	Every 2 hours from 0 to 96 hours postsurgery
Secondary	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.	Every 2 hours from 0 to 72 hours postsurgery
Secondary	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.	Every 2 hours from 0 to 48 hours postsurgery
Secondary	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.	Every 2 hours from 0 to 24 hours postsurgery
Secondary	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.	Every 2 hours from 12 to 24 hours postsurgery
Secondary	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.	Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26
Secondary	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.	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
Secondary	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.	Days 5, 8, 15 and 29
Secondary	Number of Doses of Rescue Medications Used		Up to 96 hours postsurgery