Clinical trial NCT00414024: Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Opioid-induced Constipation
Keywords: Opioid, constipation, tegaserod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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:

1. Hard or very hard stools
2. sensation of incomplete evacuation
3. straining while having a bowel movement

Exclusion Criteria:

* 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

Primary outcomes:
measure: To evaluate the long term safety of tegaserod
Secondary outcomes:
measure: Change from baseline assessment of OIC symptoms at weeks 24 and 52
measure: Change from baseline assessment of opioid-induced mid/upper GI symptoms at weeks 24 and 52
measure: Patients weekly assessment of intensity of pain for which opioids were prescribed at weeks 24 and 52
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: 60 Investigative Sites
state: New Jersey
city: Hong Kong
country: China
facility: 2 Investigative Sites
city: Egypt
country: Egypt
facility: 6 Investigative Sites
city: Singapore
country: Singapore
facility: 1 Investigative Site
city: Taiwan
country: Taiwan
facility: 2 Investigative Sites
city: Venezuela
country: Venezuela
facility: 4 Investigative Sites
Study officials:
affiliation: NPC
name: Novartis Pharmaceuticals Corp.
role: PRINCIPAL_INVESTIGATOR
References: