DyspepsiaPhase 3NCT00171470
The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.
A Phase 3 study testing Tegaserod in people with Dyspepsia, run by Novartis at 1 site in United States.
Trial summary
Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Tegaserod
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Aug 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
- Adult, Older adult
Who may be able to join
- Female patients 18 years or older.
- Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating)
- Stable dose PPI therapy of at least 4 weeks
Who cannot join
- History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions.
- Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form.
- With a current most bothersome symptom of heartburn.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
http://www.novartisclinicaltrials.com/etrials/DiseaseID21/Dyspepsia-clinical-trials.go
East Hanover, New Jersey, 07936
About this study
Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.
- Conditions
- Dyspepsia
- Being tested
- Tegaserod
- Keywords
- dyspepsia, hearburn, female, PPI
- Medical subject headings
- Dyspepsia
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 determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment)
Secondary outcomes (3)
Comparison of tegaserod vs. placebo for individual symptoms severity scores of postmeal fullness, early fullness while eating, bloating, abdominal pain, nausea, vomiting, heartburn, regurgitation and constipation (daily assessment)
Quality of Life (weekly assessment)
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 posted15 Sep 2005 (estimated)
- Study startApr 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis, Study director, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171470
- Sponsor's protocol ID
- CHTF919DUS46
- Status last verified
- Jan 2008
- First submitted
- 12 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
- The Role of Tegaserod Therapy in the Management of Dyspeptic Symptoms in Female Patients on Proton Pump Inhibitors for the Treatment of Heartburn.
- ClinicalTrials.gov ID
- NCT00171470
- Acronym / sponsor ID
- CHTF919DUS46
- Conditions
- Dyspepsia
- Keywords
- dyspepsia, hearburn, female, PPI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Aug 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.
Study to provide initial data to assess the safety and efficacy of tegaserod use in patients with dyspepsia that are being treated with proton pump inhibitors (PPI's) for heartburn.
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
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female patients 18 years or older.
- Self-reported presence of symptoms consistent with dyspepsia (including mid-upper abdominal discomfort characterized by post prandial fullness, early satiety and bloating)
- Stable dose PPI therapy of at least 4 weeks
Key exclusion criteria (4 listed)
- History of intestinal obstruction, symptomatic gallbladder disease, suspected sphincter of Oddi dysfunction, or of abdominal adhesions.
- Evidence that the dyspeptic symptoms are relieved by defecation and/or associated with a change in frequency or stool form.
- With a current most bothersome symptom of heartburn.
- 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 determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment)
3 secondary outcomes
Comparison of tegaserod vs. placebo for individual symptoms severity scores of postmeal fullness, early fullness while eating, bloating, abdominal pain, nausea, vomiting, heartburn, regurgitation and constipation (daily assessment)
Quality of Life (weekly assessment)
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.
- Novartis patient recruitment websiteLink provided by the sponsor.
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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 Dyspepsia, run by Novartis 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: 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 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 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?
To determine whether tegaserod administered over 6 weeks results in improved dyspeptic symptoms characterized by epigastric discomfort vs placebo on patients taking PPIs for the treatment of heartburn (weekly global assessment). 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.