ConstipationPhase 2NCT02820714
A Pilot Study of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
A Phase 2 study testing BLI801 Laxative in people with Constipation, run by Braintree Laboratories at 3 sites in United States.
Trial summary
The objective of this study is to evaluate BLI801 laxative in adults experiencing non-idiopathic constipation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- BLI801 Laxative
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2016to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects at least 18 years of age
- Taking medication known to cause constipation. This medication should remain stable throughout the study.
- Constipated, defined by the following criteria: Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for the previous 4 weeks:
- Straining during > 25% of defecations
- Lumpy or hard stools in > 25% of defecations
- Sensation of incomplete evacuation for > 25% of defecations
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- Onset of constipation must coincide with the instruction of treatment with a constipating medication
- Otherwise in good health, as determined by physical exam and medical history
- If female, and of child-bearing potential, is using an acceptable form of birth control
- Negative urine pregnancy test at screening (visit 1), if applicable
- In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
Who cannot join
- Subjects whose constipation diagnosis and symptoms predate the initiation of treatment with the constipating medication.
- Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
- Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
- Medical conditions associated with diarrhea, intermittent loose stools, or constipation, which could confound the interpretation of the results, eg, fecal incontinence or irritable bowel syndrome. Subjects with irritable bowel syndrome (IBS) that has been previously diagnosed by a physician prior to initiation of the constipating therapy and that meets the following criteria, are excluded:
- Absence of a structural or biochemical explanation for the abdominal pain symptom
- At least 12 weeks during a period of 12 months, of abdominal discomfort or pain with at least 2 of the following 3 features:
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- Relieved with defecation, and/or
- Onset associated with a change in frequency of stool, and/or
- Onset associated with a change in form of stool.
- Subjects taking other prohibited concomitant medications.
- Subjects who are pregnant or nursing, or intend to become pregnant during the study
- Subjects of childbearing potential who refuse a pregnancy test
- Subjects who are allergic to any BLI801 component
- Active substance or alcohol use that, in the opinion of the investigator, could compromise patient's ability to comply with the study instructions.
- Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
- Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
- Subjects who withdraw consent at any time prior to completion of Visit 1 procedures
- Subjects who have had a colonoscopy within 2 weeks of Visit 1 or are scheduled to have a colonoscopy during their participation in the study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Braintree Research Site 3
Bastrop, Louisiana, 71220
Braintree Research Site 2
Chattanooga, Tennessee, 37421
Braintree Research Site 1
Mobile, Alabama, 36688
About this study
The objective of this study is to evaluate BLI801 laxative in adults experiencing non-idiopathic constipation.
- Conditions
- Constipation
- Being tested
- BLI801 Laxative
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI801 LaxativeDrug
BLI801 Laxative
| Study group | Role | What they receive |
|---|---|---|
| BLI801 Laxative | Experimental | BLI801 oral laxative Receives: Drug: BLI801 Laxative |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of subjects with treatment response
Greater than or equal to 3 spontaneous bowel movements per week for 2 out of 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
% of subjects with treatment emergent adverse events
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McGowan, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820714
- Sponsor's protocol ID
- BLI801-204
- Status last verified
- Sep 2018
- First submitted
- 29 Jun 2016
- Last updated
- 28 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of BLI801 Laxative in Adults Experiencing Non-Idiopathic Constipation
- ClinicalTrials.gov ID
- NCT02820714
- Acronym / sponsor ID
- BLI801-204
- Conditions
- Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate BLI801 laxative in adults experiencing non-idiopathic constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BLI801 Laxative | Experimental | Drug: BLI801 LaxativeBLI801 oral laxative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects at least 18 years of age
- Taking medication known to cause constipation. This medication should remain stable throughout the study.
- Constipated, defined by the following criteria: Fewer than 3 spontaneous defecations per week and at least one of the following symptoms for the previous 4 weeks:
- Onset of constipation must coincide with the instruction of treatment with a constipating medication
- Otherwise in good health, as determined by physical exam and medical history
Key exclusion criteria (18 listed)
- Subjects whose constipation diagnosis and symptoms predate the initiation of treatment with the constipating medication.
- Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
- Subjects who have had major surgery 30 days before Visit 1; appendectomy or cholecystectomy 60 days before Visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before Visit 1; bariatric surgery or surgery to remove a segment of the GI tract at any time before Visit 1
- Medical conditions associated with diarrhea, intermittent loose stools, or constipation, which could confound the interpretation of the results, eg, fecal incontinence or irritable bowel syndrome. Subjects with irritable bowel syndrome (IBS) that has been previously diagnosed by a physician prior to initiation of the constipating therapy and that meets the following criteria, are excluded:
- Subjects taking other prohibited concomitant medications.
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 |
|---|---|---|
| BLI801 LaxativeBLI801 Laxative | Drug | BLI801 Laxative |
Primary outcome
% of subjects with treatment response
Time frame: 4 weeks
Greater than or equal to 3 spontaneous bowel movements per week for 2 out of 4 weeks
1 secondary outcome
% of subjects with treatment emergent adverse events
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
- Individual participant dataSharing planned: No
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Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
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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.
John McGowan study director
Braintree Laboratories, Inc.
3 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 BLI801 Laxative in people with Constipation, run by Braintree Laboratories at 3 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 11 inclusion and 18 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 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
% of subjects with treatment response (time frame: 4 weeks). 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 28 Sep 2018.