Opioid-induced Constipation Clinical Trial
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01965652 -
Long Term Safety of Naldemedine
|
Phase 3 | |
| Completed |
NCT04173858 -
Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol
|
||
| Recruiting |
NCT05149833 -
European Study of Opioid Induced Constipation
|
||
| Completed |
NCT01186770 -
A Study of Oral Methylnaltrexone (MNTX) for the Treatment of Opioid-Induced Constipation (OIC) in Participants With Chronic, Non-Malignant Pain
|
Phase 3 | |
| Completed |
NCT02270983 -
Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain
|
Phase 2 | |
| Completed |
NCT00640146 -
Study of Subcutaneous Methylnaltrexone (MNTX) in the Treatment of Opioid-Induced Constipation During Rehabilitation After Orthopedic Procedures
|
Phase 2 | |
| Terminated |
NCT01696643 -
Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
|
Phase 3 | |
| Completed |
NCT01993940 -
Efficacy and Safety of Naldemedine in Treating Opioid-induced Constipation
|
Phase 3 | |
| Terminated |
NCT00399659 -
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
|
Phase 3 | |
| Terminated |
NCT01901302 -
Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
|
Phase 3 | |
| Withdrawn |
NCT00858754 -
Study Evaluating Safety & Efficacy of Subcutaneous Methylnaltrexone on Opioid-Induced Constipation in Cancer Subjects
|
Phase 4 | |
| Completed |
NCT05770960 -
Colonic Motor Patterns in Healthy Volunteers
|
Phase 4 | |
| Terminated |
NCT01384292 -
Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain
|
Phase 3 | |
| Completed |
NCT00672477 -
Study Evaluating Subcutaneous Methylnaltrexone For Treatment Of Opioid-Induced Constipation In Patients With Advanced Illness
|
Phase 4 | |
| Recruiting |
NCT03687268 -
Naloxone HCl PR Tablets in Patients With Opioid Induced Constipation
|
Phase 3 | |
| Completed |
NCT00672139 -
Safety of Subcutaneous Methylnaltrexone for Opioid-Induced Constipation in Patients With Advanced Illness
|
Phase 4 | |
| Terminated |
NCT01901341 -
The Efficacy and Safety Study of CB-5945 for the Treatment of Opioid-Induced Constipation
|
Phase 3 | |
| Recruiting |
NCT03720613 -
Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain
|
||
| Completed |
NCT01368562 -
Compassionate Use Study of Methylnaltrexone
|
N/A | |
| Completed |
NCT01040637 -
A Multiple Dose Study of TD-1211 in Healthy Volunteers and Patients With Opioid-Induced Constipation
|
Phase 1/Phase 2 |