ConstipationPhase 2NCT01301781
BLI801 Laxative in Constipated Adults
A Phase 2 study testing BLI801 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 BLI801 vs. placebo 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2011to May 2011
- 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
- Constipated, defined by ROME III definition
- Subject has < 3 satisfactory BMs during the run-in period
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 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
Advanced Clinical Research Institute
Anaheim, California, 92801
Long Island GI Research Group
Great Neck, New York, 11023
Jupiter Research
Jupiter, Florida, 33458
United Medical Research
New Smyrna Beach, Florida, 32168
About this study
Official title: A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults
A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.
- Conditions
- Constipation
- Being tested
- BLI801, Placebo
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI801Drug
BLI801 laxative - oral solution
PlaceboDrug
BLI801 placebo - oral solution
| Study group | Role | What they receive |
|---|---|---|
| BLI801 laxative | Experimental | BLI801 laxative - oral solution Receives: Drug: BLI801 |
| Placebo | Placebo comparator | BLI801 placebo - oral solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose
Measured: 3 hours
Secondary outcomes (2)
percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose
Measured: 3 hours
serum chemistry
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01301781
- Sponsor's protocol ID
- BLI801-201
- Status last verified
- Sep 2012
- First submitted
- 22 Feb 2011
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults
- ClinicalTrials.gov ID
- NCT01301781
- Acronym / sponsor ID
- BLI801-201
- Conditions
- Constipation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- First posted
- 23 Feb 2011 (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 BLI801 vs. placebo in constipated adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BLI801 laxative | Experimental | Drug: BLI801BLI801 laxative - oral solution |
| Placebo | Placebo comparator | Drug: PlaceboBLI801 placebo - oral solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Constipated, defined by ROME III definition
- Subject has < 3 satisfactory BMs during the run-in period
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 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 |
|---|---|---|
| BLI801BLI801 laxative - oral solution | Drug | BLI801 laxative |
| PlaceboBLI801 placebo - oral solution | Drug | Placebo |
Primary outcome
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose
Time frame: 3 hours
2 secondary outcomes
percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose
Time frame: 3 hours
serum chemistry
Time frame: 7 days
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 1 Oct 2012.
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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.
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 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 2 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 1 Oct 2012. 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. 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?
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?
percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose (time frame: 3 hours). 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 1 Oct 2012.