AbdominoplastyPhase 2NCT03429556
Study to Evaluate Botulinum Neurotoxin Serotype E (EB-001) in Reducing Musculoskeletal Pain in Abdominoplasty
A Phase 2 study testing Botulinum Neurotoxin Serotype E in people with Abdominoplasty, run by Allergan at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 23 to 55 years
- Conditions the study is for
- Abdominoplasty
- What is being tested?
- Botulinum Neurotoxin Serotype E
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2018to 10 Jul 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Huntington Ambulatory Surgery Center
Pasadena, California, 91105
Lotus Clinical Research, LLC
Pasadena, California, 91105
About this study
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
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.
- Conditions
- Abdominoplasty
- Being tested
- Botulinum Neurotoxin Serotype E, Placebo
- Keywords
- pain, neurotoxin
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Neurotoxin Serotype EBiological
Also called EB-001, BoNT/E
Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.
PlaceboDrug
Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. Receives: Drug: Placebo |
| Botulinum Neurotoxin Serotype E Dose 1 | Experimental | Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery. Receives: Biological: Botulinum Neurotoxin Serotype E |
| Botulinum Neurotoxin Serotype E Dose 2 | Experimental | Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. Receives: Biological: Botulinum Neurotoxin Serotype E |
| Botulinum Neurotoxin Serotype E Dose 3 | Experimental | Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. Receives: Biological: Botulinum Neurotoxin Serotype E |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 2 hours from 12 to 96 hours postsurgery
Secondary outcomes (9)
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.
Measured: Every 2 hours from 0 to 96 hours postsurgery
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.
Measured: Every 2 hours from 0 to 72 hours postsurgery
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.
Measured: Every 2 hours from 0 to 48 hours postsurgery
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.
Measured: Every 2 hours from 0 to 24 hours postsurgery
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.
Measured: Every 2 hours from 12 to 24 hours postsurgery
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.
Measured: Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26
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.
Measured: 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
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.
Measured: Days 5, 8, 15 and 29
Number of Doses of Rescue Medications Used
Measured: Up to 96 hours postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start8 May 2018
- Primary completion10 Jul 2018
- Study completion10 Jul 2018
Why it stopped: Sponsor decision to terminate early
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AbdominoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joan-En Lin, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429556
- Sponsor's protocol ID
- EB001-ABD201
- Status last verified
- Aug 2019
- First submitted
- 6 Feb 2018
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03429556
- Acronym / sponsor ID
- EB001-ABD201
- Conditions
- Abdominoplasty
- Keywords
- pain, neurotoxin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to terminate early
- Enrolment
- 23 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 10 Jul 2018 (actual)
- Study completion
- 10 Jul 2018 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. |
| Botulinum Neurotoxin Serotype E Dose 1 | Experimental | Biological: Botulinum Neurotoxin Serotype ESingle botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery. |
| Botulinum Neurotoxin Serotype E Dose 2 | Experimental | Biological: Botulinum Neurotoxin Serotype ESingle botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. |
| Botulinum Neurotoxin Serotype E Dose 3 | Experimental | Biological: Botulinum Neurotoxin Serotype ESingle botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. |
Who may qualify
- Ages
- 23 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Neurotoxin Serotype EAlso: EB-001, BoNT/ESingle botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery. | Biological | Botulinum Neurotoxin Serotype E Dose 1, Botulinum Neurotoxin Serotype E Dose 2, Botulinum Neurotoxin Serotype E Dose 3 |
| PlaceboPlacebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. | Drug | Placebo |
Primary outcome
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)
Time frame: Every 2 hours from 12 to 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.
9 secondary outcomes
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 96 Hours Postsurgery
Time frame: Every 2 hours from 0 to 96 hours postsurgery
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 72 Hours Postsurgery (AUC0-72)
Time frame: Every 2 hours from 0 to 72 hours postsurgery
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 48 Hours Postsurgery (AUC0-48)
Time frame: Every 2 hours from 0 to 48 hours postsurgery
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 0 and 24 Hours Postsurgery (AUC0-24)
Time frame: Every 2 hours from 0 to 24 hours postsurgery
AUC of Participant's Assessment of Pain Using the NPRS at Rest Between 12 and 24 Hours Postsurgery (AUC12-24)
Time frame: Every 2 hours from 12 to 24 hours postsurgery
Participants Overall Assessment of Pain Using the NPRS After Discharge
Time frame: Days 6, 7, 8, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24 and 26
Participant's Overall Assessment of Pain Using the NPRS-Activity (NPRS-A)
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
Number of Participants by Patient Global Assessment (PGA) of Pain Control Score Categories
Time frame: Days 5, 8, 15 and 29
Number of Doses of Rescue Medications Used
Time frame: Up to 96 hours postsurgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan-En Lin study director
Allergan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Botulinum Neurotoxin Serotype E in people with Abdominoplasty, run by Allergan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Every 2 hours from 12 to 96 hours postsurgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019; AzTrials last refreshed its copy on 29 Oct 2026.