Chronic ConstipationPhase 4NCT00348634
Effect of Tegaserod on Orocecal Transit in Elderly Chronic Constipation Patients
A Phase 4 study testing Tegaserod in people with Chronic Constipation, run by Novartis at 3 sites in United States.
Trial summary
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Tegaserod
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2006to Apr 2007
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- Older adult
Who may be able to join
- Male \& Females aged 65 and older
- Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks
- Patients must have had a colonoscopy within the past 5 years
- Patients must pass a balloon expulsion test at screening
- Patients must be able to comply and understand the use of a diary
Who cannot join
- Patients with a clinically significant medical condition that would interfere with the patient completing the trial
- Patients with loose stools at least once per week
- Patients with IBS
- Known allergies to the same class of drug and/or allergies to eggs
- Patients who require the use of manual maneuvers to have a bowel movement
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109-0362
Arkansas Gastroenterology, PA
North Little Rock, Arizona, 72117
Temple University Hospital
Philadelphia, Pennsylvania, 19140
About this study
Official title: The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.
- Conditions
- Chronic Constipation
- Being tested
- Tegaserod
- Keywords
- Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying
- Medical subject headings
- Constipation
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.
Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
Secondary outcomes (1)
Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: Terminated early due to regulatory action suspending tegaserod use in 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Temple University, University of Michigan
- Responsible party
- Sponsor
- Investigators
- Henry Parkman, MD, Study chair, TempleWilliam Chey, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00348634
- Sponsor's protocol ID
- CHTF919EUS51
- Status last verified
- Mar 2016
- First submitted
- 3 Jul 2006
- Last updated
- 4 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tegaserod on Orocecal Transit in Elderly Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT00348634
- Acronym / sponsor ID
- CHTF919EUS51
- Conditions
- Chronic Constipation
- Keywords
- Constipation, Tegaserod, orocecal transit, colonic transit, gastric emptying
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to regulatory action suspending tegaserod use in 2007
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Temple University, University of Michigan
- Study start
- Jul 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 4 Jul 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.
This study will evaluate the effects of tegaserod on orocecal and colonic transit in patients over 65 years with chronic constipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Male \& Females aged 65 and older
- Patients must meet the criteria for chronic idiopathic constipation for at least 12 weeks
- Patients must have had a colonoscopy within the past 5 years
- Patients must pass a balloon expulsion test at screening
- Patients must be able to comply and understand the use of a diary
Key exclusion criteria (6 listed)
- Patients with a clinically significant medical condition that would interfere with the patient completing the trial
- Patients with loose stools at least once per week
- Patients with IBS
- Known allergies to the same class of drug and/or allergies to eggs
- Patients who require the use of manual maneuvers to have a bowel movement
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
Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy
1 secondary outcome
Whole gut transit and stomach emptying: Following 2 weeks of treatment, the rate of transit of food through the colon and stomach will be measured using scintigraphy
Results and safety
The study was stopped early (reason given: Terminated early due to regulatory action suspending tegaserod use in 2007). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2016.
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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.
Henry Parkman, MD study chair
Temple
William Chey, MD study chair
University of Michigan
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegaserod in people with Chronic Constipation, run by Novartis 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 5 inclusion and 6 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 4 Mar 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Terminated early due to regulatory action suspending tegaserod use in 2007). 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?
Orocecal transit: Time of radioactive marker to reach the cecum using scintigraphy. 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 4 Mar 2016.