DyspepsiaPhase 3NCT00232024
Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
A Phase 3 study testing Tegaserod in people with Dyspepsia, run by Novartis at 1 site in United States.
Trial summary
This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo. 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
- 1,296 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to May 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, 18 years or older
- Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia for at least 12 weeks, not necessarily consecutive, during the previous 12 months.
Who cannot join
- Abnormal upper GI endoscopy findings such as esophageal, gastric erosions or ulcers and/or duodenal ulcers/erosions.
- Any of the following symptoms: heartburn, epigastric pain, nausea or vomiting.
- Other protocol-defined inclusion/exclusion criteria may appl
Trial locations and contacts
1 site in 1 country.
About this study
This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.
- Conditions
- Dyspepsia
- Being tested
- Tegaserod
- Keywords
- Dyspepsia, gastrointestinal, tegaserod
- 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.
Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating)
Secondary outcomes (6)
Average severity score during each week.
Percentage of days with satisfactory relief of dyspepsia during each week.
Weekly global assessment of change in dyspepsia condition.
Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
Quality of life at end of treatment compared to baseline.
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 posted4 Oct 2005 (estimated)
- Study startJan 2004
- Study completionMay 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
- 1,296 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
- NCT00232024
- Sponsor's protocol ID
- CHTF919D2301
- Status last verified
- Jan 2008
- First submitted
- 8 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
- Assessment of Efficacy and Safety of Tegaserod Treatment and Placebo in Women With Dyspepsia
- ClinicalTrials.gov ID
- NCT00232024
- Acronym / sponsor ID
- CHTF919D2301
- Conditions
- Dyspepsia
- Keywords
- Dyspepsia, gastrointestinal, tegaserod
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,296 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- May 2006 (actual)
- First posted
- 4 Oct 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.
This study is being done to evaluate the safety, tolerability and satisfactory relief of dyspepsia symptoms in females excluding those with predominant stomach pain. Tegaserod will be evaluated at 6mg twice daily and placebo.
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 (2 listed)
- Female, 18 years or older
- Self-reported presence of persistent or recurrent adverse digestive symptoms consistent with dyspepsia for at least 12 weeks, not necessarily consecutive, during the previous 12 months.
Key exclusion criteria (3 listed)
- Abnormal upper GI endoscopy findings such as esophageal, gastric erosions or ulcers and/or duodenal ulcers/erosions.
- Any of the following symptoms: heartburn, epigastric pain, nausea or vomiting.
- Other protocol-defined inclusion/exclusion criteria may appl
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
Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating)
6 secondary outcomes
Average severity score during each week.
Percentage of days with satisfactory relief of dyspepsia during each week.
Weekly global assessment of change in dyspepsia condition.
Daily assessment of improvment of individual symptoms postprandial fullness early satiety, bloating, abdominal pain, nausea and vomiting.
Quality of life at end of treatment compared to baseline.
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 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 2 inclusion and 3 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?
Over 6 weeks of treatment assessment of percent of days with satisfactory relief of dyspepsia and/or average severity score in (average of post-prandial fullness early satiety and bloating). 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.