Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain

Sponsor

Bausch Health Americas, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00366431

Collaborator

(none)

420

Enrollment

Locations

Duration (Months)

6.3

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain.

Condition or Disease	Intervention/Treatment	Phase
Constipation	Drug: MOA-728	Phase 2

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Non-Malignant Pain

Study Start Date :

Aug 1, 2006

Actual Study Completion Date :

Mar 1, 2007

Outcome Measures

Primary Outcome Measures

The effect of the interventional treatment will be measured by the change from baseline in the number of bowel movements per week during the double-blind treatment period. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adult outpatients with opioid-induced bowel dysfunction and chronic non-malignant pain.
Taking oral, transdermal, intravenous, or subcutaneous opioids.
Willingness to discontinue all pre-study laxative therapy and utilize only study permitted rescue laxatives.

Exclusion Criteria:

History of chronic constipation before the initiation of opioid therapy.
Other GI disorders known to affect bowel transit.
Women who are pregnant, breast-feeding, or plan to become pregnant.

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35215
2	Birmingham	Alabama	United States	35244
3	Mobile	Alabama	United States	36608
4	Phoenix	Arizona	United States	85029
5	Tucson	Arizona	United States	85710
6	Tucson	Arizona	United States	85712
7	Tucson	Arizona	United States	85741
8	Hot Springs	Arkansas	United States	71913
9	Anaheim	California	United States	92801
10	Anaheim	California	United States	92805
11	Bakersfield	California	United States	93311
12	Foothill Ranch	California	United States	92610
13	Garden Grove	California	United States	92843
14	Los Gatos	California	United States	95032
15	Orange	California	United States	92869
16	Sacramento	California	United States	95831
17	San Diego	California	United States	92108
18	San Diego	California	United States	92120
19	San Diego	California	United States	92121
20	Trumbull	Connecticut	United States	06611
21	Hollywood	Florida	United States	33021
22	Jacksonville	Florida	United States	32216
23	Jupiter	Florida	United States	33458
24	Largo	Florida	United States	33770
25	Miami	Florida	United States	33173
26	Miami	Florida	United States	33180
27	Ocala	Florida	United States	34471
28	Ormond Beach	Florida	United States	32174
29	Saint Cloud	Florida	United States	34769
30	Tampa	Florida	United States	33607
31	West Palm Beach	Florida	United States	33401
32	Dawsonville	Georgia	United States	30534
33	Marietta	Georgia	United States	30060
34	Marietta	Georgia	United States	30066
35	Bloomington	Illinois	United States	61701
36	Chicago	Illinois	United States	60610
37	Indianapolis	Indiana	United States	46250
38	Elkridge	Maryland	United States	21075
39	Boston	Massachusetts	United States	02115
40	Brockton	Massachusetts	United States	02301
41	Saginaw	Michigan	United States	48602
42	Traverse City	Michigan	United States	49684
43	Picayune	Mississippi	United States	39466
44	Independence	Missouri	United States	64055
45	Missoula	Montana	United States	59808
46	Omaha	Nebraska	United States	68114
47	Reno	Nevada	United States	89502
48	Haddon Heights	New Jersey	United States	08035
49	Albuquerque	New Mexico	United States	87102
50	Great Neck	New York	United States	11023
51	Lake Success	New York	United States	11042
52	Charlotte	North Carolina	United States	28210
53	Winston-Salem	North Carolina	United States	27103
54	Cincinnati	Ohio	United States	45219
55	Cincinnati	Ohio	United States	45224
56	Dayton	Ohio	United States	45439
57	Clinton	Oklahoma	United States	73601
58	Chattanooga	Tennessee	United States	37404
59	Beaumont	Texas	United States	77701
60	Colleyville	Texas	United States	76034
61	San Antonio	Texas	United States	78205
62	San Antonio	Texas	United States	78209
63	San Antonio	Texas	United States	78238
64	Alexandria	Virginia	United States	22304
65	Christiansburg	Virginia	United States	24073
66	Norfolk	Virginia	United States	23502
67	Richmond	Virginia	United States	23229