ConstipationPhase 2/3NCT00365820
Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain
A Phase 2/3 study testing Tegaserod in people with Constipation, run by Novartis at 59 sites in United States.
Trial summary
This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constipation
- What is being tested?
- Tegaserod
- How many people
- 670 participants
- Where
- 59 sitesUnited States
- Study dates
- Jul 2006to Apr 2007
- Phase
- Phase 2/3
- 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 and female outpatients 18 years of age or older.
- Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.
- Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
- Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:
- less than 3 spontaneous bowel movements per week and at least one of the following on at least 25% of occasions:
- hard or very hard stools
- sensation of incomplete evacuation
- straining while having a bowel movement
Who cannot join
- Patients who are receiving opioids for abdominal pain or connective tissue disorders.
- Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
- Patients who underwent major surgery within 3 months prior to screening.
- Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
- Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
59 sites in 1 country.
59 sites in 1 country
United States59 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
Colleyville, Texas, 76034
Investigative Site
Corsicana, Texas, 75110
Investigative Site
Dayton, Ohio, 45440
Investigative Site
DeLand, Florida, 32720
Investigative Site
Downey, California, 90240
Novartis Pharmaceutical Corporation
East Hanover, New Jersey, 07936-1080
Investigative Site
Encinitas, California, 92024
Investigative Site
Evansville, Indiana, 47714
Investigative Site
Fountain Valley, California, 92708
Investigative Site
Greensboro, North Carolina, 27401
Investigative Site
Hershey, Pennsylvania, 17033-085
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, North Carolina, 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
Portland, Oregon, 97232
Investigative Site
Prairie Village, Kansas, 66206
Investigative Site
Salt Lake City, Utah, 84132
Investigative Site
San Antonio, Texas, 78229
Investigative Site
San Diego, California, 92103
Investigative Site
San Francisco, California, 94115
Investigative Site
Seattle, Washington, 98104
Investigative Site
Shreveport, Louisiana, 71103
Investigative Site
Springhill, Florida, 34609
Investigative Site
Tampa, Florida, 33607
Investigative Site
Torrance, California, 90505
Investigative Site
Tucson, Arizona, 85712
Investigative Site
Winston-Salem, North Carolina, 27103
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
- Conditions
- Constipation
- Being tested
- Tegaserod
- Keywords
- Opioid, constipation, tegaserod, Opioid-induced constipation
- Medical subject headings
- Constipation, Opioid-Induced 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.
Change from baseline in the number of bowel movements over weeks 1-4
Secondary outcomes (3)
Change from baseline in the number of bowel movements over weeks 1-12
Change from baseline in abdominal distension/bloating over weeks 1-12
Change from baseline in abdominal discomfort/pain over weeks 1-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2006 (estimated)
- Study startJul 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 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 670 participants
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharma AG, Study chair, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365820
- Sponsor's protocol ID
- CHTF919N2201
- Status last verified
- Apr 2012
- First submitted
- 17 Aug 2006
- Last updated
- 20 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Multicenter Phase II/III Study to Evaluate the Efficacy and Safety of Tegaserod and Placebo Given Orally for 12 Weeks for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
- ClinicalTrials.gov ID
- NCT00365820
- Acronym / sponsor ID
- CHTF919N2201
- Conditions
- Constipation
- Keywords
- Opioid, constipation, tegaserod, Opioid-induced constipation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early as a result of regulatory action suspending tegaserod use in 2007
- Enrolment
- 670 participants
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 18 Aug 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 efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female outpatients 18 years of age or older.
- Patients with chronic non-cancer pain that necessitates the use of non-injectable opioid analgesics. The equivalent dose of 300 mg morphine per day is the maximum opioid analgesic dose allowed. In general, patients should be using opioids on a daily basis.
- Chronic pain which has been present for a minimum of 3 months which needs the chronic use of opioids for pain relief.
- Constipation, according to the investigator's clinical judgment, that is resulting from opioid use for non-cancer chronic pain. Opioid-induced constipation (OIC) is defined as follows:
Key exclusion criteria (6 listed)
- Patients who are receiving opioids for abdominal pain or connective tissue disorders.
- Planned discontinuation or an increase or decrease by more than 30% of the current opioid dose
- Patients who underwent major surgery within 3 months prior to screening.
- Patients with a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
- Patients with a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
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
Change from baseline in the number of bowel movements over weeks 1-4
3 secondary outcomes
Change from baseline in the number of bowel movements over weeks 1-12
Change from baseline in abdominal distension/bloating over weeks 1-12
Change from baseline in abdominal discomfort/pain over weeks 1-12
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 20 Apr 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 Pharma AG study chair
Novartis Pharmaceuticals
59 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tegaserod in people with Constipation, run by Novartis at 59 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 8 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: stopped early, as of the sponsor's last update on 20 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in the number of bowel movements over weeks 1-4. 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 20 Apr 2012.