Opioid-induced ConstipationPhase 3NCT00399659
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
A Phase 3 study testing Tegaserod in people with Opioid-induced Constipation, run by Novartis at 57 sites in United States.
Trial summary
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows: Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-induced Constipation
- What is being tested?
- Tegaserod
- How many people
- 360 participants
- Where
- 57 sitesUnited States
- Study dates
- Nov 2006to Apr 2007
- 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
- Patient has completed the 12 week double blind treatment of study CHTF919N2201
Who cannot join
- Planned discontinuation of opioids during the study.
- Development of any of the medical conditions listed as exclusion criteria for the CHTF919N2201 study.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
United States57 sites
Investigative Site
Avon, Indiana, 46123
Investigative Site
Beaumont, Texas, 77701
Investigative Site
Belleville, Illinois, 62220
Investigative Site
Boston, Massachusetts, 02118
Investigative Site
Boston, Massachusetts, 02215
Investigative Site
Bristol, Connecticut, 06010
Investigative Site
Buena Park, California, 90620
Investigative Site
Charlotte, North Carolina, 28210
Investigative Site
Charlottesville, Virginia, 22903
Investigative Site
Chattanooga, Tennessee, 37404
Investigative Site
Chicago, Illinois, 60640
Investigative Site
Corsicana, Texas, 75110
Investigative Site
DeLande, Florida, 32720
Investigative Site
Downey, California, 90240
Investigative Site
Encinitas, California, 92024
Investigative Site
Evansville, Indiana, 47714
Investigative Site
Fountain Valley, California, 92708
Investigative Site
Greensboro, North Carolina, 27401
Investigative Site
Houston, Texas, 77005
Investigative Site
Indianapolis, Indiana, 46254
Investigative Site
Jacksonville, Florida, 32207
Investigative Site
La Jolla, California, 92037
Investigative Site
Largo, Florida, 33773
Investigative Site
Levittown, Pennsylvania, 19056
Investigative Site
Los Angeles, California, 90073
Investigative Site
Miami, Florida, 33176
Investigative Site
Mission Viejo, California, 92691
Investigative Site
Mobile, Alabama, 36608
Investigative Site
Monroe, California, 28112
Investigative Site
New Smyrna Beach, Florida, 32168
Investigative Site
New York, New York, 10016
Investigative Site
New York, New York, 10022
Investigative Site
North Little Rock, Arkansas, 72117
Investigative Site
North Massapequa, New York, 11758
Investigative Site
Northglenn, Colorado, 80234
Investigative Site
Oklahoma City, Oklahoma, 73112
Investigative Site
Omaha, Nebraska, 68114
Investigative Site
Omaha, Nebraska, 68134
Investigative Site
Overland Park, Kansas, 66212
Investigative Site
Pahrump, Nevada, 89048
Investigative Site
Phoenix, Arizona, 85029
Investigative Site
Phoenix, Arizona, 85050
Investigative Site
Prairie Village, Kansas, 66206
Investigative Site
Salt Lake City, Utah, 84132
Investigative Site
San Diego, California, 92103
Investigative Site
San Diego, California, 92117
Investigative Site
San Francisco, California, 94115
Investigative Site
Sarasota, Florida, 34239
Investigative Site
Seattle, Washington, 98104
Investigative Site
Shreveport, Louisiana, 71103
Investigative Site
Springhill, Florida, 34609
Investigative Site
Tampa, Florida, 33607
Investigative Site
Topeka, Kansas, 66606
Investigative Site
Torrance, California, 90505
Investigative Site
Tucson, Arizona, 85712
Investigative Site
Wellesley Hills, Massachusetts, 02481-2106
Investigative Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A 52-week Extension to Study CHTF919N2201 to Evaluate the Safety and Efficacy of Tegaserod (6 mg b.i.d. and 12 mg o.d.) Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain.
Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows:
Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study will remain on the same dose in the extension (double-blind).
Patients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label)
Patients who enter this study AFTER the core study interim analysis will receive the selected tegaserod dose regimen (open-label) determined by the core study IA.
- Conditions
- Opioid-induced Constipation
- Being tested
- Tegaserod
- Keywords
- Opioid, constipation, tegaserod
- Medical subject headings
- Opioid-Induced Constipation, Constipation
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.
Long term safety of tegaserod
Secondary outcomes (3)
Change from baseline assessment of OIC symptoms, at week 24 and 52
Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionApr 2007
- Study completionApr 2007
Why it stopped: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-induced 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals Corp., Study chair, NPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399659
- Sponsor's protocol ID
- CHTF919N2201E1
- Status last verified
- Apr 2012
- First submitted
- 14 Nov 2006
- Last updated
- 1 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week Extension to Study CHTF919N2201 to Evaluate the Safety and Efficacy of Tegaserod (6 mg b.i.d. and 12 mg o.d.) Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
- ClinicalTrials.gov ID
- NCT00399659
- Acronym / sponsor ID
- CHTF919N2201E1
- Conditions
- Opioid-induced Constipation
- Keywords
- Opioid, constipation, tegaserod
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
- Enrolment
- 360 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Nov 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Nov 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.
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain.
Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows:
Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study will remain on the same dose in the extension (double-blind).
Patients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label)
Patients who enter this study AFTER the core study interim analysis will receive the selected tegaserod dose regimen (open-label) determined by the core study IA.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient has completed the 12 week double blind treatment of study CHTF919N2201
Key exclusion criteria (3 listed)
- Planned discontinuation of opioids during the study.
- Development of any of the medical conditions listed as exclusion criteria for the CHTF919N2201 study.
- 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
Long term safety of tegaserod
3 secondary outcomes
Change from baseline assessment of OIC symptoms, at week 24 and 52
Change from baseline assessment of opioid-induced mid/upper GI symptoms, at week 24 and 52
Patients' weekly assessment of intensity of pain for which opioids were prescribed, at week 24 and 52
Results and safety
The study was stopped early (reason given: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
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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 Pharmaceuticals Corp. study chair
NPC
57 sites 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 Opioid-induced Constipation, run by Novartis at 57 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 1 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: stopped early, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 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 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 was stopped early (reason given: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007). Results are not available in the source record.
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?
Long term safety of tegaserod. 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 May 2012.