Constipation PredominantPhase 3NCT00171431
The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)
A Phase 3 study testing Tegaserod in people with Constipation Predominant and Irritable Bowel Syndrome (IBS-C), run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Constipation Predominant, Irritable Bowel Syndrome (IBS-C)
- What is being tested?
- Tegaserod
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to May 2006
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female 18 and older
- IBS-C patients diagnosed on the basis of Rome II criteria
- Ability to comply with the requirements of the entire study
Who cannot join
- Evidence of structural abnormality of the gastrointestinal tract or disease/conditions.
- Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy.
- Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.
- Being tested
- Tegaserod
- Keywords
- IBS-C, female
- 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.
TegaserodDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C
by using Multiple Intraluminal Impedance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionMay 2006
- Study completionMay 2006
Why it stopped: This study was terminated early in May 2006 due to low patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation PredominantStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171431
- Sponsor's protocol ID
- CHTF919AUS33
- Status last verified
- Apr 2012
- First submitted
- 12 Sep 2005
- Last updated
- 20 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tegaserod on Patterns of Flow in the Small Bowel of Patients With Irritable Bowel Syndrome (IBS)
- ClinicalTrials.gov ID
- NCT00171431
- Acronym / sponsor ID
- CHTF919AUS33
- Keywords
- IBS-C, female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early in May 2006 due to low patient enrollment
- Enrolment
- 20 participants
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 15 Sep 2005 (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.
Evaluation of the effect of tegaserod treatment on small intestinal motility and flow pattern in female IBS-C patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female 18 and older
- IBS-C patients diagnosed on the basis of Rome II criteria
- Ability to comply with the requirements of the entire study
Key exclusion criteria (4 listed)
- Evidence of structural abnormality of the gastrointestinal tract or disease/conditions.
- Patients with previous gastrointestinal surgery other than appendectomy or cholecystectomy.
- Evidence of cathartic colon or a history of laxative use, that in the investigator's opinion is consistent with severe laxative dependence such that the patient is likely to require or use laxatives during the study
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| Tegaserod | Drug | – |
Primary outcome
To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C
by using Multiple Intraluminal Impedance
Results and safety
The study was stopped early (reason given: This study was terminated early in May 2006 due to low patient enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 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.
Novartis study director
Novartis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tegaserod in people with Constipation Predominant and Irritable Bowel Syndrome (IBS-C), run by Novartis Pharmaceuticals 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 3 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Apr 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: This study was terminated early in May 2006 due to low patient enrollment). Results are not available in the source record.
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?
To evaluate the effects of tegaserod on motility and small intestinal flow patterns after meal in female patients with IBS-C. The study lists 2 primary outcomes in all. 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 20 Apr 2012.