ConstipationPhase 2NCT01687985
A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults
A Phase 2 study testing BLI801 laxative - low dose and BLI801 laxative - high dose in people with Constipation, run by Braintree Laboratories at 4 sites in United States.
Trial summary
A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults. 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 - low dose and BLI801 laxative - high dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 4 sitesUnited States
- Study dates
- Aug 2012to Mar 2013
- 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
- Constipated, defined by ROME definition:
- Otherwise in good health, as determined by physical exam and medical history
Who cannot join
- Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
- Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments
- Subjects who are allergic to any BLI801 component
- Subjects currently taking narcotic analgesics or other medications known to cause constipation
- 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 have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
- Subjects with an active history of drug or alcohol abuse
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Anaheim Clinical Trials
Anaheim, California, 92801
Commonwealth Clinical Studies
Brockton, Massachusetts, 02302
Clinsearch
Chattanooga, Tennessee, 37421
Memphis Gastroenterology
Germantown, Tennessee, 38138
About this study
A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults.
- Conditions
- Constipation
- Being tested
- BLI801 laxative - low dose, BLI801 laxative - high dose
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI801 laxative - low doseDrug
BLI801 laxative - oral solution
BLI801 laxative - high doseDrug
Also called BLI801
BLI801 laxative - oral solution
| Study group | Role | What they receive |
|---|---|---|
| BLI801 laxative - low dose | Experimental | BLI801 laxative - oral solution Receives: Drug: BLI801 laxative - low dose |
| BLI801 laxative - high dose | Experimental | BLI801 laxative - oral solution Receives: Drug: BLI801 laxative - high dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Success
percent of patients experiencing a response in 3 out of 4 weeks of treatment
Measured: 4 weeks
Secondary outcomes (1)
serum chemistry
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 posted19 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionMar 2013
- Study completionMar 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John McGowan, MPH, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687985
- Sponsor's protocol ID
- BLI801-202
- Status last verified
- Jul 2014
- First submitted
- 14 Sep 2012
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Evaluation of BLI801 Laxative in Constipated Adults
- ClinicalTrials.gov ID
- NCT01687985
- Acronym / sponsor ID
- BLI801-202
- Conditions
- Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 19 Sep 2012 (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.
A pilot study to evaluate the safety and efficacy of multiple BLI801 doses in constipated adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLI801 laxative - low dose | Experimental | Drug: BLI801 laxative - low doseBLI801 laxative - oral solution |
| BLI801 laxative - high dose | Experimental | Drug: BLI801 laxative - high doseBLI801 laxative - oral solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects at least 18 years of age
- Otherwise in good health, as determined by physical exam and medical history
Key exclusion criteria (7 listed)
- Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
- Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments
- Subjects who are allergic to any BLI801 component
- Subjects currently taking narcotic analgesics or other medications known to cause constipation
- Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
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 laxative - low doseBLI801 laxative - oral solution | Drug | BLI801 laxative - low dose |
| BLI801 laxative - high doseAlso: BLI801BLI801 laxative - oral solution | Drug | BLI801 laxative - high dose |
Primary outcome
Treatment Success
Time frame: 4 weeks
percent of patients experiencing a response in 3 out of 4 weeks of treatment
1 secondary outcome
serum chemistry
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 16 Jul 2014.
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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, MPH study director
Braintree Laboratories, Inc.
4 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 - low dose and BLI801 laxative - high dose in people with Constipation, run by Braintree Laboratories at 4 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 7 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Treatment Success (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 16 Jul 2014.