Chronic ConstipationPhase 4NCT00149877
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
A Phase 4 study testing Tegaserod in people with Chronic Constipation, run by Novartis at 1 site in Switzerland.
Trial summary
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Constipation
- What is being tested?
- Tegaserod
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2004to Feb 2006
- 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 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Male and females of at least 18 years of age
- A 12-month history of constipation (defined as < three spontaneous bowel movements per week and ≥1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining)
Who cannot join
- Patients with cancer, inflammatory bowel disease or other structural bowel disease
- Patients who participated in a prior tegaserod study
- Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.
- Conditions
- Chronic Constipation
- Being tested
- Tegaserod
- Keywords
- Chronic constipation, tegaserod
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.
Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
Secondary outcomes (5)
Number of csbm during 8 weeks of treatment.
Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.
Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.
Laxative use.
Safety and tolerability.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startApr 2004
- Study completionFeb 2006
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
- 250 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study chair, Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00149877
- Sponsor's protocol ID
- CHTF919EHK01
- Status last verified
- Jan 2008
- First submitted
- 6 Sep 2005
- Last updated
- 1 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation
- ClinicalTrials.gov ID
- NCT00149877
- Acronym / sponsor ID
- CHTF919EHK01
- Conditions
- Chronic Constipation
- Keywords
- Chronic constipation, tegaserod
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- Feb 2006 (actual)
- First posted
- 8 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.
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and females of at least 18 years of age
- A 12-month history of constipation (defined as < three spontaneous bowel movements per week and ≥1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining)
Key exclusion criteria (4 listed)
- Patients with cancer, inflammatory bowel disease or other structural bowel disease
- Patients who participated in a prior tegaserod study
- Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders
- 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
Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.
5 secondary outcomes
Number of csbm during 8 weeks of treatment.
Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation.
Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain.
Laxative use.
Safety and tolerability.
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 Feb 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.
Novartis study chair
Basel
1 site 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 1 site in Switzerland.
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 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: finished, as of the sponsor's last update on 1 Feb 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 Switzerland. 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 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?
Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment.. 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 Feb 2008.