Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
Sponsor
Novartis (Industry)
Overall Status
Terminated
CT.gov ID
NCT00399659
Collaborator
(none)
360
57
5
6.3
1.3
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
360 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date
:
Nov 1, 2006
Actual Primary Completion Date
:
Apr 1, 2007
Actual Study Completion Date
:
Apr 1, 2007
Outcome Measures
Primary Outcome Measures
- Long term safety of tegaserod []
Secondary Outcome Measures
- 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 []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- Patient has completed the 12 week double blind treatment of study CHTF919N2201
Exclusion Criteria:
-
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigative Site | Mobile | Alabama | United States | 36608 |
| 2 | Investigative Site | Phoenix | Arizona | United States | 85029 |
| 3 | Investigative Site | Phoenix | Arizona | United States | 85050 |
| 4 | Investigative Site | Tucson | Arizona | United States | 85712 |
| 5 | Investigative Site | North Little Rock | Arkansas | United States | 72117 |
| 6 | Investigative Site | Buena Park | California | United States | 90620 |
| 7 | Investigative Site | Downey | California | United States | 90240 |
| 8 | Investigative Site | Encinitas | California | United States | 92024 |
| 9 | Investigative Site | Fountain Valley | California | United States | 92708 |
| 10 | Investigative Site | La Jolla | California | United States | 92037 |
| 11 | Investigative Site | Los Angeles | California | United States | 90073 |
| 12 | Investigative Site | Mission Viejo | California | United States | 92691 |
| 13 | Investigative Site | Monroe | California | United States | 28112 |
| 14 | Investigative Site | San Diego | California | United States | 92103 |
| 15 | Investigative Site | San Diego | California | United States | 92117 |
| 16 | Investigative Site | San Francisco | California | United States | 94115 |
| 17 | Investigative Site | Torrance | California | United States | 90505 |
| 18 | Investigative Site | Northglenn | Colorado | United States | 80234 |
| 19 | Investigative Site | Bristol | Connecticut | United States | 06010 |
| 20 | Investigative Site | DeLande | Florida | United States | 32720 |
| 21 | Investigative Site | Jacksonville | Florida | United States | 32207 |
| 22 | Investigative Site | Largo | Florida | United States | 33773 |
| 23 | Investigative Site | Miami | Florida | United States | 33176 |
| 24 | Investigative Site | New Smyrna Beach | Florida | United States | 32168 |
| 25 | Investigative Site | Sarasota | Florida | United States | 34239 |
| 26 | Investigative Site | Springhill | Florida | United States | 34609 |
| 27 | Investigative Site | Tampa | Florida | United States | 33607 |
| 28 | Investigative Site | Belleville | Illinois | United States | 62220 |
| 29 | Investigative Site | Chicago | Illinois | United States | 60640 |
| 30 | Investigative Site | Avon | Indiana | United States | 46123 |
| 31 | Investigative Site | Evansville | Indiana | United States | 47714 |
| 32 | Investigative Site | Indianapolis | Indiana | United States | 46254 |
| 33 | Investigative Site | Overland Park | Kansas | United States | 66212 |
| 34 | Investigative Site | Prairie Village | Kansas | United States | 66206 |
| 35 | Investigative Site | Topeka | Kansas | United States | 66606 |
| 36 | Investigative Site | Shreveport | Louisiana | United States | 71103 |
| 37 | Investigative Site | Boston | Massachusetts | United States | 02118 |
| 38 | Investigative Site | Boston | Massachusetts | United States | 02215 |
| 39 | Investigative Site | Wellesley Hills | Massachusetts | United States | 02481-2106 |
| 40 | Investigative Site | Omaha | Nebraska | United States | 68114 |
| 41 | Investigative Site | Omaha | Nebraska | United States | 68134 |
| 42 | Investigative Site | Pahrump | Nevada | United States | 89048 |
| 43 | Investigative Site | New York City | New York | United States | 10022 |
| 44 | Investigative Site | New York | New York | United States | 10016 |
| 45 | Investigative Site | North Massapequa | New York | United States | 11758 |
| 46 | Investigative Site | Charlotte | North Carolina | United States | 28210 |
| 47 | Investigative Site | Greensboro | North Carolina | United States | 27401 |
| 48 | Investigative Site | Winston Salem | North Carolina | United States | 27103 |
| 49 | Investigative Site | Oklahoma City | Oklahoma | United States | 73112 |
| 50 | Investigative Site | Levittown | Pennsylvania | United States | 19056 |
| 51 | Investigative Site | Chattanooga | Tennessee | United States | 37404 |
| 52 | Investigative Site | Beaumont | Texas | United States | 77701 |
| 53 | Investigative Site | Corsicana | Texas | United States | 75110 |
| 54 | Investigative Site | Houston | Texas | United States | 77005 |
| 55 | Investigative Site | Salt Lake City | Utah | United States | 84132 |
| 56 | Investigative Site | Charlottesville | Virginia | United States | 22903 |
| 57 | Investigative Site | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Novartis
Investigators
- Study Chair: Novartis Pharmaceuticals Corp., NPC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00399659
Other Study ID Numbers:
- CHTF919N2201E1
First Posted:
Nov 15, 2006
Last Update Posted:
May 1, 2012
Last Verified:
Apr 1, 2012
Keywords provided by Novartis
Additional relevant MeSH terms: