Musculoskeletal PainPhase 2NCT03193593
Study to Evaluate EB-001 in Reducing Musculoskeletal Pain
A Phase 2 study testing EB-001 in people with Musculoskeletal Pain, run by Bonti, Inc. at 1 site in United States.
Trial summary
To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- EB-001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2017to 7 Aug 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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women 18 to 55 years of age, inclusive
- Women who are in good health as determined by medical history, physical examination, clinical laboratory studies, ECGs, vital signs, and Investigator judgment
- Scheduled to undergo primary breast augmentation under general anesthesia (endotracheal or otherwise) with:
- Sub-pectoral implants placement,
- Infra-mammary surgical approach,
- Implant size between 250 and 400cc and
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- Non-textured saline breast implants
- American Society of Anesthesiologist (ASA) Physical Class 1-2
- Women of non-childbearing potential or postmenopausal (at least 12 consecutive months of amenorrhea)
- Women of childbearing potential must not be pregnant, lactating, or planning to become pregnant during the study
- Women of childbearing potential agreeing to use either:
- a highly effective method of contraception with failures rates less than 1% per year such as implant, intrauterine device (IUD), or confirmed sterilization and sterilization procedure at least 3 months prior to the day of dosing
- dual methods of contraception with overall failures rate less than 1% per year such as injectable, pill, patch, ring, and diaphragm from the day of dosing for 3 months (subjects using oral contraception must have initiated treatment at least 2 months prior to the day of dosing)
- Willing and able to complete protocol requirements and instructions, which includes completion of all required visits, procedures and in-clinic stays until the end of the study
- Willing and able to sign and date IRB-approved informed consent
- Able to speak, read, and understand the language of the informed consent form (ICF) and study questionnaires
Who cannot join
- History of surgical procedure involving the breast, including, but not limited to, breast augmentation. History of minor localized breast biopsy is not exclusionary if it occurred at least 1 year prior to the screening visit, and if considered not clinically significant in the opinion of the investigator.
- Pre-existing lung disease that could impact subject safety in the opinion of the investigator
- History of smoking within the past two years
- Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender
- Pulse oximetry below 95%
- Body weight less than 50 kg (110 pounds) or a Body Mass Index (BMI) of ≥ 32
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- Documented diagnosis of chronic pain condition, or other painful pre-operative condition that, in the opinion of the investigator, may require analgesic treatment in the post-operative period (e.g. significant joint pain, neuropathic pain)
- Known hypersensitivity to any botulinum toxin serotype or to any component of the formulation
- Reported use of any botulinum toxin within 3 months prior to the date of surgery
- Anticipated use of any botulinum toxin of any serotype during the study
- 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
- Pre-existing disorders of the neuromuscular junction (myasthenia gravis, Eaton- Lambert syndrome, or amyotrophic lateral Sclerosis)
- Any past or current medical condition that in opinion of investigator, puts subject at undue safety risk for surgical complications or for use of the investigational product.
- Any clinically significant psychiatric condition that, in opinion of investigator, may interfere with study assessments or protocol compliance
- History of alcohol or drug abuse in the last 3 years, based on investigator judgement
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days or 5 half-lives of the drug, whichever is longer, of entry into this study
- Subject plans to donate blood or plasma from 30 days prior to screening until last follow-up visit (Day 29)
- Reported pain score of 2 or more at screening on the 11-point scale NPRS-A following strength testing with PM activation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Placebo-Controlled, Double Blind, Ascending Dose Cohort Study to Evaluate Safety and Efficacy of EB-001 IM Injections in Reducing Musculoskeletal Pain in Subjects Undergoing Elective Augmentation Mammoplasty (Breast Augmentation)
To determine the safety and efficacy of single intra-operative treatment of EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants
Read the detailed description
This study will evaluate the safety and efficacy of EB-001 in decreasing post-surgical pain in patients undergoing surgical breast augmentation with subpectoral placement of the implants. Intramuscular (IM) injection of EB-001 into the PM bilaterally during surgery may decrease pain related to stretching of the PM by the implants.
The safety objective is to determine the safety and tolerability of single intraoperative treatment of EB-001 IM injections into the PM in subjects undergoing breast augmentation with subpectoral implants.
The efficacy objective is to evaluate the efficacy of intraoperative administration of EB-001 IM into the PM in reducing the pain and use of rescue pain medications in subjects undergoing breast augmentation with subpectoral implants.
- Conditions
- Musculoskeletal Pain
- Being tested
- Placebo, EB-001
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo- Single injection of saline into Pectoralis Muscle
EB-001Drug
Single injection of EB-001 into Pectoralis Muscle
| Study group | Role | What they receive |
|---|---|---|
| Placebo Injections | Placebo comparator | Intervention: Drug: Placebo
Single Saline Injection into the Pectoralis Muscle Receives: Drug: Placebo |
| EB-001 Dose 1 | Active comparator | Intervention: Drug: EB-001
1st Dose in escalation paradigm. Single Injection of active drug into the pectoralis muscle Receives: Drug: EB-001 |
| EB-001 Dose 2 (1.6X) | Active comparator | Intervention: Drug: EB-001
2nd Dose in escalation paradigm, 1.6X Dose 1. Single Injection of active drug into the pectoralis muscle Receives: Drug: EB-001 |
| EB-001 Dose 3 (3.3X) | Active comparator | Intervention: Drug: EB-001
3rd Dose in escalation paradigm, 3.3X Dose 1. Single Injection of active drug into the pectoralis muscle Receives: Drug: EB-001 |
| EB-001 Dose 4 (6.7X) | Active comparator | Intervention: Drug: EB-001
4th Dose in escalation paradigm, 6.7X Dose 1. Single Injection of active drug into the pectoralis muscle Receives: Drug: EB-001 |
| EB-001 Dose 5 (10X) | Active comparator | Intervention: Drug: EB-001
5th Dose in escalation paradigm, 10X Dose 1. Single Injection of active drug into the pectoralis muscle Receives: Drug: EB-001 |
| EB-001 Dose 6 (13.3X) | Active comparator | Intervention: Drug: EB-001
6th Dose in escalation paradigm, 13.3X Dose 1. Single Injection of active drug into the pectoralis muscle Receives: Drug: EB-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h)
Subject's assessment of pain using the Numeric Pain Rating Scale (1= No Pain, 10= Maximum Pain) for the first 96 hours following injection, expressed as AUC over the 16h to 96h period following dosing.
Measured: 16 hours to 96 hours following dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start29 Aug 2017
- Primary completion26 Apr 2018
- Study completion7 Aug 2018
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 Musculoskeletal PainStudies 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bonti, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03193593
- Sponsor's protocol ID
- EB001-MA201
- Status last verified
- Jan 2019
- First submitted
- 19 Jun 2017
- Last updated
- 25 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Placebo-Controlled, Double Blind, Ascending Dose Cohort Study to Evaluate Safety and Efficacy of EB-001 IM Injections in Reducing Musculoskeletal Pain in Subjects Undergoing Elective Augmentation Mammoplasty (Breast Augmentation)
- ClinicalTrials.gov ID
- NCT03193593
- Acronym / sponsor ID
- EB001-MA201
- Conditions
- Musculoskeletal Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bonti, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 26 Apr 2018 (actual)
- Study completion
- 7 Aug 2018 (actual)
- First posted
- 21 Jun 2017 (actual)
- Results
- Posted 25 Jan 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 EB-001 IM injections into the Pectoralis Major (PM) in subjects undergoing breast augmentation with subpectoral implants
Detailed description
This study will evaluate the safety and efficacy of EB-001 in decreasing post-surgical pain in patients undergoing surgical breast augmentation with subpectoral placement of the implants. Intramuscular (IM) injection of EB-001 into the PM bilaterally during surgery may decrease pain related to stretching of the PM by the implants.
The safety objective is to determine the safety and tolerability of single intraoperative treatment of EB-001 IM injections into the PM in subjects undergoing breast augmentation with subpectoral implants.
The efficacy objective is to evaluate the efficacy of intraoperative administration of EB-001 IM into the PM in reducing the pain and use of rescue pain medications in subjects undergoing breast augmentation with subpectoral implants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Placebo Injections | Placebo comparator | Drug: PlaceboIntervention: Drug: Placebo Single Saline Injection into the Pectoralis Muscle |
| EB-001 Dose 1 | Active comparator | Drug: EB-001Intervention: Drug: EB-001 1st Dose in escalation paradigm. Single Injection of active drug into the pectoralis muscle |
| EB-001 Dose 2 (1.6X) | Active comparator | Drug: EB-001Intervention: Drug: EB-001 2nd Dose in escalation paradigm, 1.6X Dose 1. Single Injection of active drug into the pectoralis muscle |
| EB-001 Dose 3 (3.3X) | Active comparator | Drug: EB-001Intervention: Drug: EB-001 3rd Dose in escalation paradigm, 3.3X Dose 1. Single Injection of active drug into the pectoralis muscle |
| EB-001 Dose 4 (6.7X) | Active comparator | Drug: EB-001Intervention: Drug: EB-001 4th Dose in escalation paradigm, 6.7X Dose 1. Single Injection of active drug into the pectoralis muscle |
| EB-001 Dose 5 (10X) | Active comparator | Drug: EB-001Intervention: Drug: EB-001 5th Dose in escalation paradigm, 10X Dose 1. Single Injection of active drug into the pectoralis muscle |
| EB-001 Dose 6 (13.3X) | Active comparator | Drug: EB-001Intervention: Drug: EB-001 6th Dose in escalation paradigm, 13.3X Dose 1. Single Injection of active drug into the pectoralis muscle |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Women 18 to 55 years of age, inclusive
- Women who are in good health as determined by medical history, physical examination, clinical laboratory studies, ECGs, vital signs, and Investigator judgment
- Scheduled to undergo primary breast augmentation under general anesthesia (endotracheal or otherwise) with:
- American Society of Anesthesiologist (ASA) Physical Class 1-2
- Women of non-childbearing potential or postmenopausal (at least 12 consecutive months of amenorrhea)
Key exclusion criteria (19 listed)
- History of surgical procedure involving the breast, including, but not limited to, breast augmentation. History of minor localized breast biopsy is not exclusionary if it occurred at least 1 year prior to the screening visit, and if considered not clinically significant in the opinion of the investigator.
- Pre-existing lung disease that could impact subject safety in the opinion of the investigator
- History of smoking within the past two years
- Slow vital capacity that is below 80% of normal value for respective race, age, height, and gender
- Pulse oximetry below 95%
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 |
|---|---|---|
| PlaceboPlacebo- Single injection of saline into Pectoralis Muscle | Drug | Placebo Injections |
| EB-001Single injection of EB-001 into Pectoralis Muscle | Drug | EB-001 Dose 1, EB-001 Dose 2 (1.6X), EB-001 Dose 3 (3.3X), EB-001 Dose 4 (6.7X), EB-001 Dose 5 (10X), EB-001 Dose 6 (13.3X) |
Primary outcome
Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h)
Time frame: 16 hours to 96 hours following dosing
Subject's assessment of pain using the Numeric Pain Rating Scale (1= No Pain, 10= Maximum Pain) for the first 96 hours following injection, expressed as AUC over the 16h to 96h period following dosing.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EB-001 in people with Musculoskeletal Pain, run by Bonti, Inc. at 1 site 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 16 inclusion and 19 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: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 25 Jan 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?
Subject's Assessment of Pain Using the Numeric Pain Rating Scale (AUC16h-96h) (time frame: 16 hours to 96 hours following dosing). 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 25 Jan 2019.