Opioid-induced ConstipationPhase 3NCT00414024
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 6 sites in 6 countries.
Trial summary
This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation in patients with non-cancer pain. Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows: Patients will be randomly assigned to receive open label tegaserod 6 mg… 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
- 11 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Feb 2007to May 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
- 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.
- 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
- 1. Who are receiving opioids for abdominal pain or connective tissue disorders.
- Planned discontinuation of opioids during the study
- Who underwent major surgery within 3 months prior to screening.
- With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
- With a current diagnosis of irritable bowel syndrome (IBS) constipation predominant or alternators.
- With a previous use of tegaserod within 3 months prior to baseline.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod 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 in patients with non-cancer pain.
Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows:
Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1.
Patients who enter this study AFTER the core study interim analysis receive the treatment as follows:
Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.
- 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.
To evaluate the long term safety of tegaserod
Secondary outcomes (3)
Change from baseline assessment of OIC symptoms at weeks 24 and 52
Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52
Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 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 posted20 Dec 2006 (estimated)
- Study startFeb 2007
- Primary completionMay 2007
- Study completionMay 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
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals Corp., Principal investigator, NPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414024
- Sponsor's protocol ID
- CHTF919N2302
- Status last verified
- Apr 2012
- First submitted
- 19 Dec 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
- An Open Label 52-week Study to Evaluate the Safety and Efficacy of Tegaserod Given Orally for the Treatment of Opioid-induced Constipation (OIC) in Patients With Chronic Non-cancer Pain
- ClinicalTrials.gov ID
- NCT00414024
- Acronym / sponsor ID
- CHTF919N2302
- 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
- 11 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 20 Dec 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 in patients with non-cancer pain.
Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis receive the treatment as follows:
Patients will be randomly assigned to receive open label tegaserod 6 mg b.i.d. or tegaserod 12 mg o.d. using an allocation ratio of 1:1.
Patients who enter this study AFTER the core study interim analysis receive the treatment as follows:
Patients will be assigned to receive the selected tegaserod dose regimen (as determined by the core study interim analysis) in an open label fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
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.
- 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:
Key exclusion criteria (7 listed)
- 1. Who are receiving opioids for abdominal pain or connective tissue disorders.
- Planned discontinuation of opioids during the study
- Who underwent major surgery within 3 months prior to screening.
- With a history of prior chronic constipation (CC) that was present for more than three months and that was not related to opioid use.
- 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
To evaluate the long term safety of tegaserod
3 secondary outcomes
Change from baseline assessment of OIC symptoms at weeks 24 and 52
Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52
Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 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 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 Pharmaceuticals Corp. principal investigator
NPC
6 sites in 6 countries: 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 6 sites in 6 countries.
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 7 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 6 sites in United States, China, Egypt, Singapore, Taiwan and 1 more country. 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?
To evaluate the 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 20 Apr 2012.