Irritable Bowel SyndromePhase 2NCT00399438
A Study of BMS-562086 in Patients With Irritable Bowel Syndrome
A Phase 2 study testing BMS-562086 in people with Irritable Bowel Syndrome, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome (D-IBS) Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- BMS-562086
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jan 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire
Who cannot join
- Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose-Ranging Study of the Pharmacodynamic Effects of BMS-562086 on Gastrointestinal Transit in Women With Diarrhea-Predominant Irritable Bowel Syndrome
The primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome (D-IBS)
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Placebo, BMS-562086
- Keywords
- Diarrhea-predominant irritable bowel syndrome
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Tablets, Oral, once daily, 2 weeks
BMS-562086Drug
Tablets, Oral, once daily, 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 0 mg Receives: Drug: Placebo |
| 2 | Other | 25 mg Receives: Drug: BMS-562086 |
| 3 | Other | 100 mg Receives: Drug: BMS-562086 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit
Measured: taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16
Secondary outcomes (3)
Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms.
Measured: throughout the study
Safety
Measured: Safety labs at screening, nominal study days -3, 8, 15, 42, and 70 (discharge). ECGs will be taken at screening, nominal days 5 or 6, 14, and discharge. Vital signs will be taken at screening, on nominal days 3, 4, 5, 7, 8, 10, 11, 42 and discharge
Blood pharmacokinetics
Measured: PK samples will be taken on nominal days 8, 14 (serial: predose 0.5, 1, 2, 4, 6, 9 hours post dose), 15 (pre dose and 9 hours post dose), 16, 42 and discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399438
- Sponsor's protocol ID
- CN148-013
- Status last verified
- Sep 2008
- First submitted
- 13 Nov 2006
- Last updated
- 26 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-Ranging Study of the Pharmacodynamic Effects of BMS-562086 on Gastrointestinal Transit in Women With Diarrhea-Predominant Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT00399438
- Acronym / sponsor ID
- CN148-013
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Diarrhea-predominant irritable bowel syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 14 Nov 2006 (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 primary purpose of this study is to evaluate the effects of BMS-562086 on small bowel and colonic transits in female subjects with diarrhea-predominant irritable bowel syndrome (D-IBS)
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Drug: Placebo0 mg |
| 2 | Other | Drug: BMS-56208625 mg |
| 3 | Other | Drug: BMS-562086100 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female subjects with D-IBS symptoms based on Rome II criteria and the subject's responses to the Bowel Disease Questionnaire
Key exclusion criteria (1 listed)
- Clinically significant prolonged diarrhea with dehydration requiring IV fluid within 60 days prior to baseline visit
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 |
|---|---|---|
| PlaceboTablets, Oral, once daily, 2 weeks | Drug | 1 |
| BMS-562086Tablets, Oral, once daily, 2 weeks | Drug | 2, 3 |
Primary outcome
Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit
Time frame: taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16
3 secondary outcomes
Daily diary will be used to record the effects of BMS-562086 on bowel patterns and visceral symptoms.
Time frame: throughout the study
Safety
Time frame: Safety labs at screening, nominal study days -3, 8, 15, 42, and 70 (discharge). ECGs will be taken at screening, nominal days 5 or 6, 14, and discharge. Vital signs will be taken at screening, on nominal days 3, 4, 5, 7, 8, 10, 11, 42 and discharge
Blood pharmacokinetics
Time frame: PK samples will be taken on nominal days 8, 14 (serial: predose 0.5, 1, 2, 4, 6, 9 hours post dose), 15 (pre dose and 9 hours post dose), 16, 42 and discharge
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 26 Sep 2008.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
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 BMS-562086 in people with Irritable Bowel Syndrome, run by Bristol-Myers Squibb 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 1 inclusion and 1 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 26 Sep 2008. 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. 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?
Radioscintigraphy will be used to determine the effects of BMS-562086 on gastrointestinal transit (time frame: taken at baseline on nominal study days 3,4, and 5 and post dose on nominal study days 14,15, 16). 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 26 Sep 2008.