HeartburnPhase 3NCT00171457
The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
A Phase 3 study testing Tegaserod in people with Heartburn and Dyspepsia, run by Novartis at 1 site in United States.
Trial summary
Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Tegaserod
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Sep 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
- All sexes
- Adult, Older adult
Who may be able to join
- Male or female subjects at least 18 years of age.
- Subjects willing to undergo multiple nasogastric intubations.
- Patients with functional heartburn will need to meet ROME II criteria.
- Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety)
Who cannot join
- Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS.
- Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease.
- Subjects with Diffuse Esophageal Spasm or Achalasia.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, 73104
About this study
Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach
- Being tested
- Tegaserod
- Keywords
- functional heartburn, dyspepsia, male, female, visceral sensitivity
- Medical subject headings
- Heartburn, 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 if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
Secondary outcomes (7)
1) Comparing effects at end of treatment compared to baseline:
To verify that tegaserod modulates esophageal sensitivity to esophageal distention
To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort
To determine if tegaserod improves heartburn and/or regurgitation
To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo
Safety assessment
To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi
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 completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HeartburnStudies 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
- Crossover
- Masking
- Double blind
- Enrolment
- 24 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
- NCT00171457
- Sponsor's protocol ID
- CHTF919DUS45
- Status last verified
- Oct 2007
- First submitted
- 12 Sep 2005
- Last updated
- 10 Oct 2007
- Results posted
- No
Publications
Miner PB Jr, Rodriguez-Stanley S, Proskin HM, Kianifard F, Bottoli I. Tegaserod in patients with mechanical sensitivity and overlapping symptoms of functional heartburn and functional dyspepsia. Curr Med Res Opin. 2008 Aug;24(8):2159-72. doi: 10.1185/03007990802222832. Epub 2008 Jun 17.
PubMed 18561877
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Tegaserod on Mechanical Sensitivity of the Esophagus and Stomach in Patients With Heartburn and Dyspepsia.
- ClinicalTrials.gov ID
- NCT00171457
- Acronym / sponsor ID
- CHTF919DUS45
- Keywords
- functional heartburn, dyspepsia, male, female, visceral sensitivity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Sep 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.
Investigate the role of tegaserod in modulating gastric sensitivity to mechanical distention of the stomach
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects at least 18 years of age.
- Subjects willing to undergo multiple nasogastric intubations.
- Patients with functional heartburn will need to meet ROME II criteria.
- Patients with symptoms consistent with dyspepsia (epigastric pain/discomfort characterized by bloating, postprandial fullness and early satiety)
Key exclusion criteria (4 listed)
- Subjects with clinically significant diarrhea or a diagnosis of diarrhea-predominant IBS.
- Subjects with a diagnosis of IBD, Barrett's esophagus, esophageal stricture or ring, or previous or current history of ulcer disease.
- Subjects with Diffuse Esophageal Spasm or Achalasia.
- 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 if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach
7 secondary outcomes
1) Comparing effects at end of treatment compared to baseline:
To verify that tegaserod modulates esophageal sensitivity to esophageal distention
To determine if tegaserod improves individual dyspeptic symptoms of epigastric pain/discomfort
To determine if tegaserod improves heartburn and/or regurgitation
To determine if tegaserod is preferred by patients with functional heartburn & accompanying dyspepsia & gastric mechanical sensitivity over placebo
Safety assessment
To determine if there is a correlation between esophageal & gastric mechanosensitivity thresholds in this patient group, and to determine if tegaserod alters this relationshi
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 10 Oct 2007.
- Derived from this study: PubMed 18561877Miner PB Jr, Rodriguez-Stanley S, Proskin HM, Kianifard F, Bottoli I. Tegaserod in patients with mechanical sensitivity and overlapping symptoms of functional heartburn and functional dyspepsia. Curr Med Res Opin. 2008 Aug;24(8):2159-72. doi: 10.1185/03007990802222832. Epub 2008 Jun 17.
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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 Heartburn and 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 4 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 10 Oct 2007. 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 if tegaserod 6 mg b.i.d modulates gastric sensitivity to mechanical distention of the stomach. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00171457, which also lists 1 linked publication.
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 10 Oct 2007; AzTrials last refreshed its copy on 8 Nov 2026.