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Sponsor decision to terminate early
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. |
|
| Botulinum Neurotoxin Serotype E Dose 1 | Experimental | Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery. |
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| Botulinum Neurotoxin Serotype E Dose 2 | Experimental | Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. |
|
| Botulinum Neurotoxin Serotype E Dose 3 | Experimental | Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum Neurotoxin Serotype E | Biological | Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan-En Lin | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntington Ambulatory Surgery Center | Pasadena | California | 91105 | United States | ||
| Lotus Clinical Research, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into rectus abdominus (RA) muscles during abdominoplasty surgery. |
| FG001 | Botulinum Neurotoxin Serotype E Dose 1 | Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery. |
| FG002 | Botulinum Neurotoxin Serotype E Dose 2 | Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. |
| FG003 | Botulinum Neurotoxin Serotype E Dose 3 | Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Population included all participants exposed to any amount of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. |
| BG001 | Botulinum Neurotoxin Serotype E Dose 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Modified Intent-to-treat (mITT) population included all randomized and treated participants with at least one post-injection pain score. | Posted | Mean | Standard Deviation | hour (hr)*score on a scale | Every 2 hours from 12 to 96 hours postsurgery |
|
Up to 31 days
Safety Population included all participants exposed to any amount of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area, Head | Allergan | 714-246-4500 | clinicaltrials@allergan.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 28, 2018 | Jul 2, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2018 | Jul 2, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Placebo | Drug | Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery. |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Number of Doses of Rescue Medications Used | Up to 96 hours postsurgery |
| Pasadena |
| California |
| 91105 |
| United States |
Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery.
| BG002 | Botulinum Neurotoxin Serotype E Dose 2 | Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. |
| BG003 | Botulinum Neurotoxin Serotype E Dose 3 | Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery. |
| OG002 | Botulinum Neurotoxin Serotype E Dose 2 | Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. |
| OG003 | Botulinum Neurotoxin Serotype E Dose 3 | Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. |
|
|
| 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. | mITT population included all randomized and treated participants with at least one post-injection pain score. | Posted | Mean | Standard Deviation | hr*score on a scale | 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. | mITT population included all randomized and treated participants with at least one post-injection pain score. | Posted | Mean | Standard Deviation | hr*score on a scale | 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. | mITT population included all randomized and treated participants with at least one post-injection pain score. | Posted | Mean | Standard Deviation | hr*score on a scale | 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. | mITT population included all randomized and treated participants with at least one post-injection pain score. | Posted | Mean | Standard Deviation | hr*score on a scale | 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. | mITT population included all randomized and treated participants with at least one post-injection pain score. | Posted | Mean | Standard Deviation | hr*score on a scale | 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. | mITT population included all randomized and treated participants with at least one post-injection pain score. | Posted | Mean | Standard Deviation | score on a scale | 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. | mITT population included all randomized and treated participants with at least one post-injection pain score. Participants analyzed is the number of participants with data available for analysis at the given time point. | Posted | Mean | Standard Deviation | score on a scale | 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. | mITT population included all randomized and treated participants with at least one post-injection pain score. | Posted | Count of Participants | Participants | Days 5, 8, 15 and 29 |
|
|
|
| Secondary | Number of Doses of Rescue Medications Used | mITT population included all randomized and treated participants with at least one post-injection pain score. | Posted | Mean | Standard Deviation | doses | Up to 96 hours postsurgery |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 8 |
| 12 |
| EG001 | Botulinum Neurotoxin Serotype E Dose 1 | Single botulinum neurotoxin serotype E Dose 1 injection into RA muscles during abdominoplasty surgery. | 0 | 4 | 0 | 4 | 3 | 4 |
| EG002 | Botulinum Neurotoxin Serotype E Dose 2 | Single botulinum neurotoxin serotype E Dose 2 injection into RA muscles during abdominoplasty surgery. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG003 | Botulinum Neurotoxin Serotype E Dose 3 | Single botulinum neurotoxin serotype E Dose 3 injection into RA muscles during abdominoplasty surgery. | 0 | 3 | 0 | 3 | 3 | 3 |
| Constipation | Gastrointestinal disorders | 19.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | 19.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | 19.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | 19.1 | Systematic Assessment |
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| Pruritus generalised | Skin and subcutaneous tissue disorders | 19.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | 19.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | 19.1 | Systematic Assessment |
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| Headache | Nervous system disorders | 19.1 | Systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | 19.1 | Systematic Assessment |
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| Seroma | Injury, poisoning and procedural complications | 19.1 | Systematic Assessment |
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| Transaminases increased | Investigations | 19.1 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | 19.1 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | 19.1 | Systematic Assessment |
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| Food allergy | Immune system disorders | 19.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | 19.1 | Systematic Assessment |
|
A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
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| 84 hours after surgery |
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| PGA score 2 |
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| PGA score 1 |
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| PGA score 0 |
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| Opioid |
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