ConstipationPhase 4NCT00171522
Preference of Tegaserod vs. PEG 3350 in Patients With Constipation
A Phase 4 study testing Tegaserod and Polyethylene Glycol 3350 in people with Constipation, run by Novartis at 14 sites in United States.
Trial summary
To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Constipation
- What is being tested?
- Tegaserod and Polyethylene Glycol 3350
- How many people
- 52 participants
- Where
- 14 sitesUnited States
- Study dates
- May 2005to Sep 2005
- 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
- Adult
Who may be able to join
- Females aged 18 to 64 years of age
- Patients with constipation as defined by the Rome II criteria
Who cannot join
- Patients who have been previously been treated with tegaserod and/or PEG 3350
- Evidence of cathartic colon or a history of laxative abuse or laxative dependence
- History of fecal impaction which necessitated surgical intervention
- Patients with clinically significant abnormal TSH levels at screening
- Women who are pregnant or breast feeding
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Midwest Clinical Research
Bellbrook, Ohio, 45305
Clinical Trial Management of Boca Raton, Inc.
Boca Raton, Florida, 33486
Beth Israel Deacon Medical Center
Boston, Massachusetts, 02215
Associated Pharmaceutical Research Center, Inc
Buena Park, California, 90620
Associates in Gastroenterology
Hermitage, Tennessee, 37076
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566
MBS Clinical Research, LLC
Margate City, New Jersey, 08402
Heartland Clinical Research, Inc
Omaha, Nebraska, 68134
Harmony Clinical Research
Oro Valley, Arizona, 85739
Central Phoenix Medical Clinic, LLC
Phoenix, Arizona, 85201
Health Science Center
Pratt, Kansas, 67124
National Clinical Research, Inc
Richmond, Virginia, 23294
Adobe Gastroenterology, PC
Tucson, Arizona, 85712
East Coast Clinical Research
Virginia Beach, Virginia, 23454
About this study
Official title: A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation
To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste
- Conditions
- Constipation
- Being tested
- Tegaserod and Polyethylene Glycol 3350
- Keywords
- Constipation, Tegaserod, Polyethylene Glycol 3350, PEG
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegaserod and Polyethylene Glycol 3350Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use)
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 startMay 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 52 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00171522
- Sponsor's protocol ID
- CHTF919EUS49
- Status last verified
- Mar 2016
- First submitted
- 12 Sep 2005
- Last updated
- 3 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Pilot Crossover Study to Assess the Patient Preference of Tegaserod Versus Polyethylene Glycol 3350 in Patients With Constipation
- ClinicalTrials.gov ID
- NCT00171522
- Acronym / sponsor ID
- CHTF919EUS49
- Conditions
- Constipation
- Keywords
- Constipation, Tegaserod, Polyethylene Glycol 3350, PEG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Sep 2005 (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.
To determine whether female patients have a preference for tegaserod of PEG 3350 relative to dosage form, convenience, ease of administration and taste
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females aged 18 to 64 years of age
- Patients with constipation as defined by the Rome II criteria
Key exclusion criteria (6 listed)
- Patients who have been previously been treated with tegaserod and/or PEG 3350
- Evidence of cathartic colon or a history of laxative abuse or laxative dependence
- History of fecal impaction which necessitated surgical intervention
- Patients with clinically significant abnormal TSH levels at screening
- Women who are pregnant or breast feeding
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 Polyethylene Glycol 3350 | Drug | – |
Primary outcome
To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use)
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 3 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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites 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 and Polyethylene Glycol 3350 in people with Constipation, run by Novartis at 14 sites 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 6 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 3 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 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?
To determine after 14 / 35 days of treatment if women with constipation have a preference for tegaserod compared to PEG 3350, based on the assessment of the Constipation Treatment questionnaire (satisfaction with treatment, willingness to re-use). 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 3 Mar 2016.