ConstipationPhase 2NCT00583154
A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
A Phase 2 study testing BLI-801 in people with Constipation, run by Braintree Laboratories at 3 sites in United States.
Trial summary
To compare the safety and efficacy of BLI-801 administered at 4 dose levels 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?
- BLI-801
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2007to Apr 2008
- 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 according to ROME I criteria
- 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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
- Negative urine pregnancy test at screening, if applicable
- In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study
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 for the duration of the study
- Subjects who are pregnant or lactating, or intending to become pregnant during the study
- Subjects of childbearing potential who refuse a pregnancy test
- Subjects who are allergic to any BLI-801 component.
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Anaheim, California
Study site
Cranston, Rhode Island
Study site
Cumberland, Rhode Island
About this study
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.
- Conditions
- Constipation
- Being tested
- BLI-801
- Keywords
- constipation, laxative
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLI-801Drug
Dose 1
BLI-801Drug
Dose 2
BLI-801Drug
Dose 3
BLI-801Drug
Dose 4
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BLI-801 Dose 1 Receives: Drug: BLI-801 |
| 2 | Experimental | BLI-801 Dose 2 Receives: Drug: BLI-801 |
| 3 | Experimental | BLI-801 Dose 3 Receives: Drug: BLI-801 |
| 4 | Experimental | BLI-801 Dose 4 Receives: Drug: BLI-801 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Movement Count
Measured: 24 hours
Secondary outcomes (1)
Adverse events
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionApr 2008
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
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Braintree Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John McGowan, Study director, Braintree Laboratories, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583154
- Sponsor's protocol ID
- BLI-801-101
- Status last verified
- Sep 2009
- First submitted
- 20 Dec 2007
- Last updated
- 28 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Efficacy Evaluation of BLI-801 as a Laxative in Constipated Adults
- ClinicalTrials.gov ID
- NCT00583154
- Acronym / sponsor ID
- BLI-801-101
- Conditions
- Constipation
- Keywords
- constipation, laxative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Braintree LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 31 Dec 2007 (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.
To compare the safety and efficacy of BLI-801 administered at 4 dose levels in constipated adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BLI-801BLI-801 Dose 1 |
| 2 | Experimental | Drug: BLI-801BLI-801 Dose 2 |
| 3 | Experimental | Drug: BLI-801BLI-801 Dose 3 |
| 4 | Experimental | Drug: BLI-801BLI-801 Dose 4 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects at least 18 years of age
- Constipated according to ROME I criteria
- 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 (hormonal birth control, IUD, double-barrier method, depot contraceptive, sterilized, abstinent, or vasectomized spouse)
- Negative urine pregnancy test at screening, if applicable
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 for the duration of the study
- Subjects who are pregnant or lactating, or intending to become pregnant during the study
- Subjects of childbearing potential who refuse a pregnancy test
- Subjects who are allergic to any BLI-801 component.
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 |
|---|---|---|
| BLI-801Dose 1 | Drug | 1 |
| BLI-801Dose 2 | Drug | 2 |
| BLI-801Dose 3 | Drug | 3 |
| BLI-801Dose 4 | Drug | 4 |
Primary outcome
Bowel Movement Count
Time frame: 24 hours
1 secondary outcome
Adverse events
Time frame: 24 hours
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 2009.
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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 BLI-801 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 6 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 28 Sep 2009. 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?
Bowel Movement Count (time frame: 24 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 28 Sep 2009.