Constipation and DyspepsiaPhase 4NCT00277550
The Effects of Tegaserod vs. Placebo on Whole Gut Transit Time in Patients With Chronic Constipation and Dyspepsia
A Phase 4 study of Constipation and Dyspepsia, run by Novartis.
Trial summary
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Constipation and Dyspepsia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 18 to 64 years of age
- Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:
- Less than 3 bowel movements per week
- Hard or lumpy stools
- Straining during bowel movements
- Feeling of incomplete evacuation
- Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating
Who cannot join
- Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives
- Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians
- Patients with constipation secondary to medication use as determined by the study physician
- Patients with clinically significant abnormal TSH levels at screening
- Patients that have heartburn or abdominal pain as their predominant GI symptom
- Evidence of cathartic colon or a history of laxative abuse
- Other protocol-defined inclusion/exclusion criteria may apply
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Evaluation of the Effects of Tegaserod (6 mg b.i.d) on Whole Gut Transit Time in Patients With Chronic Idiopathic Constipation and Dyspepsia
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia
- Conditions
- Constipation and Dyspepsia
- Being tested
- Tegaserod and Placebo
- Keywords
- Constipation, Tegaserod, Dyspepsia
- Medical subject headings
- Constipation, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegaserod and PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
Secondary outcomes (2)
To evaluate the PD effects of tegaserod on upper & lower GI transit
To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation and DyspepsiaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Nicholas Talley, MD, Principal investigator, Mayo ClinicMichael Crowell, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277550
- Sponsor's protocol ID
- CHTF919EUS42
- Status last verified
- Mar 2016
- First submitted
- 13 Jan 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
- A Randomized, Double-blind, Placebo-controlled Evaluation of the Effects of Tegaserod (6 mg b.i.d) on Whole Gut Transit Time in Patients With Chronic Idiopathic Constipation and Dyspepsia
- ClinicalTrials.gov ID
- NCT00277550
- Acronym / sponsor ID
- CHTF919EUS42
- Conditions
- Constipation and Dyspepsia
- Keywords
- Constipation, Tegaserod, Dyspepsia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Mayo Clinic
- First posted
- 16 Jan 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.
To demonstrate the effects of tegaserod on gastrointestinal scintigraphic orocecal transit in female patients with CC and upper GI symptoms of dyspepsia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females aged 18 to 64 years of age
- Patients must present with two or more of the following criteria for chronic constipation for at least 12 weeks prior to entering the study:
- Patients must report overlapping symptoms consistent with dyspepsia, such as mid-upper abdominal discomfort characterized by early satiety, post-meal fullness and bloating
Key exclusion criteria (7 listed)
- Patients with a recent history of, or current frequency of diarrhea occuring more than once per month off of laxatives
- Clinically significant diagnosis of pelvic outlet obstruction or pelvic floor dyssenergia as determined by the study physicians
- Patients with constipation secondary to medication use as determined by the study physician
- Patients with clinically significant abnormal TSH levels at screening
- Patients that have heartburn or abdominal pain as their predominant GI symptom
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 and Placebo | Drug | – |
Primary outcome
To determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.
2 secondary outcomes
To evaluate the PD effects of tegaserod on upper & lower GI transit
To evaluate global well-being & upper and lower GI symptoms in daily assessment of bowel habits and weekly global and individual symptom assessments
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
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.
Nicholas Talley, MD principal investigator
Mayo Clinic
Michael Crowell, PhD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Constipation and Dyspepsia, run by Novartis.
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 7 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: withdrawn, 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.
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 withdrawn before enrolling participants, so there are no results.
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 determine the effect of one week of tegaserod on the passage of content through the gut by radiological procedures.. 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.