Efficacy and Safety of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain

Sponsor

Novartis (Industry)

Overall Status

Terminated

CT.gov ID

NCT00365820

Collaborator

(none)

670

Enrollment

Locations

Duration (Months)

11.4

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy and safety of tegaserod in opioid-induced constipation in patients with non-cancer pain.

Condition or Disease	Intervention/Treatment	Phase
Constipation	Drug: Tegaserod	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Change from baseline in the number of bowel movements over weeks 1-4 []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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. 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

Exclusion Criteria:

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.

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	San Diego	California	United States	92103
14	Investigative Site	San Francisco	California	United States	94115
15	Investigative Site	Torrance	California	United States	90505
16	Investigative Site	Northglenn	Colorado	United States	80234
17	Investigative Site	Bristol	Connecticut	United States	06010
18	Investigative Site	DeLand	Florida	United States	32720
19	Investigative Site	Jacksonville	Florida	United States	32207
20	Investigative Site	Largo	Florida	United States	33773
21	Investigative Site	Miami	Florida	United States	33176
22	Investigative Site	New Smyrna Beach	Florida	United States	32168
23	Investigative Site	Springhill	Florida	United States	34609
24	Investigative Site	Tampa	Florida	United States	33607
25	Investigative Site	Belleville	Illinois	United States	62220
26	Investigative Site	Chicago	Illinois	United States	60640
27	Investigative Site	Avon	Indiana	United States	46123
28	Investigative Site	Evansville	Indiana	United States	47714
29	Investigative Site	Indianapolis	Indiana	United States	46254
30	Investigative Site	Overland Park	Kansas	United States	66212
31	Investigative Site	Prairie Village	Kansas	United States	66206
32	Investigative Site	Shreveport	Louisiana	United States	71103
33	Investigative Site	Boston	Massachusetts	United States	02118
34	Investigative Site	Boston	Massachusetts	United States	02215
35	Investigative Site	Omaha	Nebraska	United States	68114
36	Investigative Site	Omaha	Nebraska	United States	68134
37	Investigative Site	Pahrump	Nevada	United States	89048
38	Novartis Pharmaceutical Corporation	East Hanover	New Jersey	United States	07936-1080
39	Investigative Site	New York City	New York	United States	10022
40	Investigative Site	New York	New York	United States	10016
41	Investigative Site	North Massapequa	New York	United States	11758
42	Investigative Site	Charlotte	North Carolina	United States	28210
43	Investigative Site	Greensboro	North Carolina	United States	27401
44	Investigative Site	Monroe	North Carolina	United States	28112
45	Investigative Site	Winston Salem	North Carolina	United States	27103
46	Investigative Site	Dayton	Ohio	United States	45440
47	Investigative Site	Oklahoma City	Oklahoma	United States	73112
48	Investigative Site	Portland	Oregon	United States	97232
49	Investigative Site	Hershey	Pennsylvania	United States	17033-085
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	Colleyville	Texas	United States	76034
54	Investigative Site	Corsicana	Texas	United States	75110
55	Investigative Site	Houston	Texas	United States	77005
56	Investigative Site	San Antonio	Texas	United States	78229
57	Investigative Site	Salt Lake City	Utah	United States	84132
58	Investigative Site	Charlottesville	Virginia	United States	22903
59	Investigative Site	Seattle	Washington	United States	98104