Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone

• Sponsor: Sucampo Pharma Americas, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00620061
• Collaborator: (none)
• Enrollment: 439
• Locations: 123
• Arm: 1
• Actual Duration (Months): 21
• Patients Per Site: 3.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.

Condition or Disease	Intervention/Treatment	Phase
Opioid-Induced Bowel Dysfunction	Drug: Lubiprostone 24	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 439 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction
• Actual Study Start Date: Dec 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: All Participants Lubiprostone: 24 mcg capsule twice daily (BID) for 36 weeks	Drug: Lubiprostone 24; 24 mcg capsules for oral administration; Other Names: Amitiza

Outcome Measures

Primary Outcome Measures

1. Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month [Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.

2. Mean Weekly Bowel Movements (BMs) Per Month [Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)

Secondary Outcome Measures

1. Number of Participants Classified as Monthly Responders [Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed). A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.

2. Straining Associated With Spontaneous Bowel Movements by Month [Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.

3. Stool Consistency of Spontaneous Bowel Movements by Month [Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.

4. Constipation Severity by Month [Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.

5. Abdominal Bloating by Month [Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.

6. Abdominal Discomfort by Month [Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.

7. Bowel Habit Regularity by Month [Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular. The highest score is 7, but the best score is 1.

8. Treatment Effectiveness by Month [Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The highest and best score is 4.

9. Mean Weekly Complete SBMs by Month [Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

   Participants rate each SBM as complete if their bowels feel completely empty after the SBM

10. Mean Weekly Complete BMs by Month [Months 1, 2, 3, 4, 5, 6, 7, 8, and 9]

    Participants rate each BM as complete if their bowels feel completely empty after the BM

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Has completed 12 weeks of blinded treatment in NCT00595946 or NCT00597428

• Will continue to be treated consistently for chronic, non-cancer-related pain with any full agonist opiate and will continue opiate therapy for the duration of the study

• Willing to continue to abstain from use of disallowed medications as defined per protocol

Exclusion Criteria:

• Has newly diagnosed impaired renal function identified at the Screening Visit [i.e., serum creatinine concentration > 1.8 milligrams per deciliter (mg/dL)]

• Has experienced an unexplained and/or clinically significant weight loss defined as > 5% within 90 days prior to Screening Visit.

• Has plans to participate in another trial with an investigational drug or device during the course of the extension study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Birmingham Pain Center	Birmingham	Alabama	United States	35242
2	Simon Williamson Clinic, PC	Hueytown	Alabama	United States	35023
3	Alabama Orthopedic Clinic	Mobile	Alabama	United States	36608
4	Clinical Research Advantage, Inc./ Mesa Family Medical Center	Mesa	Arizona	United States	85203
5	Redpoint Research	Phoenix	Arizona	United States	85029
6	HOPE Research Institute	Phoenix	Arizona	United States	85050
7	Clinical Research Advantage, Inc.	Phoenix	Arizona	United States	85128
8	Clinical Research Advantage, Inc. / East Valley Family Physicians, PLC	Tempe	Arizona	United States	85222
9	Clinical Research Advantage, Inc.	Tempe	Arizona	United States	85282
10	Premiere Pharamaceutical Research, LLC	Tempe	Arizona	United States	85282
11	Genova Clinical Research	Tucson	Arizona	United States	85704
12	Verona Clinical Research, Inc.	Tucson	Arizona	United States	85710
13	Advanced Clinical Therapeutics, LLC	Tucson	Arizona	United States	85712
14	Paradigm Clinical Research, Inc.	Tucson	Arizona	United States	85712
15	Quality of Life Medical & Research Center, LLC	Tucson	Arizona	United States	85712
16	Wilson and Charani	Tucson	Arizona	United States	85741
17	Arkansas Pain Research	Hot Springs	Arkansas	United States	71913
18	Teton Research, LLC	Little Rock	Arkansas	United States	72205
19	Advanced Clinical Research Institute	Anaheim	California	United States	92801
20	Orange County Clinical Trials	Anaheim	California	United States	92801
21	Advanced Pain Institute	Arcadia	California	United States	91007
22	Impact Clinical Trials	Beverly Hills	California	United States	90036
23	Digestive and Liver Disease Specialists	Garden Grove	California	United States	92840
24	RX Clinical Research, Inc.	Garden Grove	California	United States	92843
25	Loma Linda University	Loma Linda	California	United States	92354
26	Pasadena Rehabilitation Institute	Pasadena	California	United States	91105
27	Northern California Research Corporation	Sacramento	California	United States	95831
28	Rider Research Group	San Francisco	California	United States	94117
29	ShahShreenath Clinical Service	Yorba Linda	California	United States	92886
30	Clinicos, LLC	Colorado Springs	Colorado	United States	80904
31	Lynn Institute of the Rockies	Colorado Springs	Colorado	United States	80907
32	Advanced Diagnostic Pain Treatment Center	New Haven	Connecticut	United States	06511
33	Meridien Research	Brooksville	Florida	United States	34601
34	Century Clinical Research Inc	Daytona Beach	Florida	United States	32117
35	International Medical Research	Daytona Beach	Florida	United States	32117
36	Clinical Physiology Associates/Clinical Study Center	Fort Myers	Florida	United States	33916
37	Southeastern Integrated Medical, PL dba Florida	Gainesville	Florida	United States	32607
38	Century Clinical Research	Holly Hill	Florida	United States	32117
39	Florida Institute of Medical Research	Jacksonville	Florida	United States	32257
40	Drug Study Institute	Jupiter	Florida	United States	33458
41	Sunrise Medical Research, Inc.	Lauderdale Lakes	Florida	United States	33319
42	Kenneth W. Ponder, MD, PA	Niceville	Florida	United States	32578
43	North Miami Research Inc.	North Miami	Florida	United States	33161
44	DMI Health Care Group, Inc.	Pinellas Park	Florida	United States	33782
45	Accord Clinical Research, LLC	Port Orange	Florida	United States	32129
46	Meridien Research	Saint Petersburg	Florida	United States	33709
47	Clinical Research of West Florida, Inc.	Tampa	Florida	United States	33603
48	Stedman Clinical Trials	Tampa	Florida	United States	33613
49	Palm Beach Research Center	West Palm Beach	Florida	United States	33409
50	Pinnacle Trials Inc.	Atlanta	Georgia	United States	30329
51	North Georgia Premier Research	Dawsonville	Georgia	United States	30534
52	Best Clinical Research	Decatur	Georgia	United States	30034
53	Drug Studies America	Marietta	Georgia	United States	30060
54	Millenium Pain Center	Bloomington	Illinois	United States	61701
55	University of Illinois at Chicago: Department of Medicine	Chicago	Illinois	United States	60612
56	Apex Medical Research, AMR, Inc	Chicago	Illinois	United States	60616
57	Redhead Research Inc.	Peoria	Illinois	United States	161614
58	MediSphere Medical Research Center, LLC	Evansville	Indiana	United States	47714
59	Davis Clinic, PC	Indianapolis	Indiana	United States	46260
60	Intergrated Clinical Trial Services, Inc	West Des Moines	Iowa	United States	50265
61	The Pain Treatment Center of the Bluegrass	Lexington	Kentucky	United States	40503
62	Louisiana Research Center, LLC	Shreveport	Louisiana	United States	71103
63	The Willis-Knighton Interventional Pain Center	Shreveport	Louisiana	United States	71105
64	Pain and Rehabilitation Medicine	Bethesda	Maryland	United States	20814
65	Columbia Medical Practice/ RxTrials, Inc.	Columbia	Maryland	United States	21045
66	Brigham and Women's Hosptial	Chestnut Hill	Massachusetts	United States	02467
67	MedVadis Research Corporation	Wellesley Hills	Massachusetts	United States	02481
68	Center for Clinical Studies	Dearborn	Michigan	United States	48124
69	Apex Medical Research, AMR, Inc.	Flint	Michigan	United States	48504
70	Professional Clinical Research - Interlochen	Interlochen	Michigan	United States	49641
71	Beyer Research	Kalamazoo	Michigan	United States	49009
72	Medical Research Associates	Traverse City	Michigan	United States	49684
73	Center for Digestive Health	Troy	Michigan	United States	48098
74	MAPS Applied Research Center	Edina	Minnesota	United States	55435
75	Medex Healthcare Research Inc.	Saint Louis	Missouri	United States	63117
76	Montana Neuroscience Institute Foundation / Montana Spine and Pain Center	Missoula	Montana	United States	59802
77	Office of Stephen H. Miller, MD	Las Vegas	Nevada	United States	89106
78	Affiliated Clinical Research, Inc.	Las Vegas	Nevada	United States	89144
79	Ladder Family Practice	Las Vegas	Nevada	United States	89146
80	Impact Clinical Trials	Las Vegas	Nevada	United States	89206
81	Gastroenterology Research Associates, LLC	Cedar Knolls	New Jersey	United States	07927
82	Central Jersey Medical Research Center	Elizabeth	New Jersey	United States	07202
83	Virtua Lumberton Family Physicians	Lumberton	New Jersey	United States	08048
84	Holy Name Hospital	Teaneck	New Jersey	United States	07666
85	Long Island Gastrointestinal Research Group	Great Neck	New York	United States	11023
86	NYU Pain Management Center	New York	New York	United States	10016
87	Research Across America	New York	New York	United States	10022
88	University of Rochester, Pain Treatment Center	Rochester	New York	United States	14642
89	Upstate Clinical Research Associates	Williamsville	New York	United States	14221
90	Duke University Medical Center	Durham	North Carolina	United States	27705
91	Carolina Research	Greenville	North Carolina	United States	27834
92	Peters Medical Research, LLC	High Point	North Carolina	United States	27262
93	The Center for Clinical Research	Winston-Salem	North Carolina	United States	27103
94	Glenway Family Medicine	Cincinnati	Ohio	United States	45238
95	The Ohio State University Medical Center	Columbus	Ohio	United States	43210
96	Hometown Urgent Care and Research	Dayton	Ohio	United States	45432
97	RAS Health Ltd.	Marion	Ohio	United States	43302
98	COR Clinical Research, LLC	Oklahoma City	Oklahoma	United States	73103
99	McBride Clinic	Oklahoma City	Oklahoma	United States	73112
100	Memorial Clinical Research	Oklahoma City	Oklahoma	United States	73134
101	Pain Research of Oregon, LLC	Eugene	Oregon	United States	97401
102	Medford Medical Clinic, LLP	Medford	Oregon	United States	97504
103	Affinity Research	Portland	Oregon	United States	97219
104	Lehigh Gastroenterology Associates	Allentown	Pennsylvania	United States	18104
105	Albert Einstein Healthcare Network Einstein Pain Institute	Philadelphia	Pennsylvania	United States	19141
106	Jeffry A. Lindenbaum DO, PC	Yardley	Pennsylvania	United States	19067
107	Trident Institute of Medical Research, LLC	North Charleston	South Carolina	United States	29406
108	Southeastern Clinical Research	Chattanooga	Tennessee	United States	37403
109	Comprehensive Pain Specialists, PLLC	Hendersonville	Tennessee	United States	37075
110	Integrity Clinical Research, LLC	Milan	Tennessee	United States	38358
111	Texas Familicare Clinical Research	Hurst	Texas	United States	76054
112	DCOL Center for Clinical Research	Longview	Texas	United States	75605
113	Advanced Research Institute	Ogden	Utah	United States	84405
114	Highland Clinical Research	Salt Lake City	Utah	United States	84124
115	New River Valley Research Institute	Christiansburg	Virginia	United States	24073
116	Digestive and Liver Disease Specialists	Norfolk	Virginia	United States	23502
117	Hampton Roads Institution for Performance and Sports Medicine	Portsmouth	Virginia	United States	23707
118	McGuire VA Medical Center	Richmond	Virginia	United States	23249
119	Northwest Gastroenterology Associates	Bellevue	Washington	United States	98004
120	VAMC Milwaukee	Milwaukee	Wisconsin	United States	53295
121	Health Sciences Centre Pain Clinic	Winnipeg	Manitoba	Canada	R3A 1R9
122	AIM Health Group London North	London	Ontario	Canada	N5X 4E7
123	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1 W8

Sponsors and Collaborators

• Sucampo Pharma Americas, LLC

Investigators

• Study Director: Global Clinical Leader, Mallinckrodt

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sucampo Pharma Americas, LLC
• ClinicalTrials.gov Identifier: NCT00620061
• Other Study ID Numbers: OBD06S1
• First Posted: Feb 21, 2008
• Last Update Posted: Jan 21, 2020
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Opioid-Induced Constipation; Lubiprostone

Study Results

Participant Flow

Recruitment Details	Participants were enrolled from 4 December 2007 to 29 September 2009 at 137 recruitment sites in the United States (n=134) and Canada (n=3)

Arm/Group Title	Lubiprostone
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 36 weeks
Period Title: Overall Study
STARTED	439
COMPLETED	286
NOT COMPLETED	153

Baseline Characteristics

Arm/Group Title	Lubiprostone
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 36 weeks
Overall Participants	439
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	49.8 (9.99)
Sex: Female, Male (Count of Participants)
Female	263 59.9%
Male	176 40.1%
Region of Enrollment (participants) [Number]
United States	436 99.3%
Canada	3 0.7%

Outcome Measures

1. Primary Outcome

Title	Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Description	A Spontaneous Bowel Movement (SBM) is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with evaluable SBM data during the given month

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID)
Measure Participants	439
Baseline	1.4 (0.98)
Month 1	4.9 (2.72)
Month 2	4.9 (2.62)
Month 3	5.0 (2.76)
Month 4	5.0 (2.71)
Month 5	5.0 (2.82)
Month 6	5.0 (2.86)
Month 7	5.1 (2.93)
Month 8	5.3 (2.91)
Month 9	5.2 (3.19)

2. Primary Outcome

Title	Mean Weekly Bowel Movements (BMs) Per Month
Description	A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat population with evaluable BM data during the given month

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID)
Measure Participants	439
Baseline	2.4 (1.38)
Month 1	5.0 (2.73)
Month 2	5.0 (2.63)
Month 3	5.2 (2.70)
Month 4	5.1 (2.67)
Month 5	5.1 (2.79)
Month 6	5.1 (2.85)
Month 7	5.2 (2.90)
Month 8	5.4 (2.88)
Month 9	5.3 (3.15)

3. Secondary Outcome

Title	Number of Participants Classified as Monthly Responders
Description	A weekly SBM frequency rate is calculated as (168 x Number of SBMs / Number of hours observed). A participant with an SBM frequency rate between 3 and 4 was considered a moderate responder. A subject with an SBM frequency rate higher than 4 was considered a full responder. If a subject was a moderate responder or full responder for at least half the weeks in a month, then he or she was considered a monthly responder.
Time Frame	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Month 1	322 73.3%
Month 2	323 73.6%
Month 3	291 66.3%
Month 4	270 61.5%
Month 5	259 59%
Month 6	250 56.9%
Month 7	239 54.4%
Month 8	233 53.1%
Month 9	202 46%

4. Secondary Outcome

Title	Straining Associated With Spontaneous Bowel Movements by Month
Description	Participants rate the straining associated with the SBM on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe The highest score is 4, and lower scores are better.
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat with evaluable data at the given time point

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Baseline	2.7 (0.87)
Month 1	1.7 (0.85)
Month 2	1.7 (0.85)
Month 3	1.6 (0.84)
Month 4	1.7 (0.83)
Month 5	1.6 (0.85)
Month 6	1.7 (0.84)
Month 7	1.7 (0.86)
Month 8	1.6 (0.87)
Month 9	1.6 (0.92)

5. Secondary Outcome

Title	Stool Consistency of Spontaneous Bowel Movements by Month
Description	Participants rate each spontaneous bowel movement on a scale where 0 = very loose, 1 = loose, 2 = normal, 3 = hard, 4 = very hard (little balls) The highest score is 4, but the best score is 2.
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat with evaluable data at the given time point

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Baseline	3.0 (0.84)
Month 1	2.3 (0.75)
Month 2	2.2 (0.73)
Month 3	2.2 (0.74)
Month 4	2.2 (0.72)
Month 5	2.2 (0.70)
Month 6	2.2 (0.68)
Month 7	2.2 (0.70)
Month 8	2.2 (0.66)
Month 9	2.2 (0.70)

6. Secondary Outcome

Title	Constipation Severity by Month
Description	Participants rate the severity of their constipation on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat with evaluable scores at the given time point

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Baseline	2.4 (0.72)
Month 1	1.5 (0.93)
Month 2	1.5 (0.94)
Month 3	1.5 (0.93)
Month 4	1.5 (0.96)
Month 5	1.4 (0.95)
Month 6	1.4 (0.94)
Month 7	1.4 (0.94)
Month 8	1.4 (0.97)
Month 9	1.4 (0.99)

7. Secondary Outcome

Title	Abdominal Bloating by Month
Description	Participants rate their bloating on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat with evaluable data at the given time point

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Baseline	2.2 (0.74)
Month 1	1.6 (0.88)
Month 2	1.5 (0.90)
Month 3	1.5 (0.91)
Month 4	1.5 (0.90)
Month 5	1.5 (0.92)
Month 6	1.5 (0.91)
Month 7	1.5 (0.93)
Month 8	1.5 (0.95)
Month 9	1.5 (0.95)

8. Secondary Outcome

Title	Abdominal Discomfort by Month
Description	Participants rate their abdominal discomfort on a scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The highest score is 4, but the best score is 0.
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat with evaluable data at the given time point

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Baseline	2.2 (0.67)
Month 1	1.5 (0.82)
Month 2	1.4 (0.82)
Month 3	1.4 (0.84)
Month 4	1.4 (0.83)
Month 5	1.4 (0.86)
Month 6	1.4 (0.85)
Month 7	1.4 (0.85)
Month 8	1.4 (0.89)
Month 9	1.4 (0.91)

9. Secondary Outcome

Title	Bowel Habit Regularity by Month
Description	Participants rate their bowel habit regularity on a balanced scale of 1 to 7 where 1=Very Regular and 7=Very Irregular. The highest score is 7, but the best score is 1.
Time Frame	Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat with evaluable data at the given time point

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Baseline	4.7 (1.59)
Month 1	3.6 (1.39)
Month 2	3.6 (1.38)
Month 3	3.5 (1.42)
Month 4	3.5 (1.45)
Month 5	3.5 (1.47)
Month 6	3.5 (1.50)
Month 7	3.5 (1.47)
Month 8	3.4 (1.49)
Month 9	3.4 (1.51)

10. Secondary Outcome

Title	Treatment Effectiveness by Month
Description	Participants rate treatment effectiveness on a scale where 0 = not at all effective, 1 = a little bit effective, 2 = moderately effective, 3 = quite a bit effective, 4 = extremely effective. The highest and best score is 4.
Time Frame	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat with evaluable data at the given time point

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Month 1	2.1 (0.98)
Month 2	2.1 (1.02)
Month 3	2.2 (1.04)
Month 4	2.2 (1.05)
Month 5	2.2 (1.05)
Month 6	2.2 (1.04)
Month 7	2.3 (1.05)
Month 8	2.3 (1.08)
Month 9	2.3 (1.09)

11. Secondary Outcome

Title	Mean Weekly Complete SBMs by Month
Description	Participants rate each SBM as complete if their bowels feel completely empty after the SBM
Time Frame	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat with evaluable data at the time point

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Month 1	3.1 (2.26)
Month 2	3.4 (2.27)
Month 3	3.6 (2.47)
Month 4	3.6 (2.40)
Month 5	3.7 (2.64)
Month 6	3.7 (2.62)
Month 7	3.9 (2.79)
Month 8	3.9 (2.69)
Month 9	4.2 (2.95)

12. Secondary Outcome

Title	Mean Weekly Complete BMs by Month
Description	Participants rate each BM as complete if their bowels feel completely empty after the BM
Time Frame	Months 1, 2, 3, 4, 5, 6, 7, 8, and 9

Outcome Measure Data

Analysis Population Description

Intent-to-treat with evaluable data at the time point

Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
Measure Participants	439
Month 1	3.1 (2.26)
Month 2	3.4 (2.28)
Month 3	3.6 (2.46)
Month 4	3.7 (2.38)
Month 5	3.8 (2.65)
Month 6	3.8 (2.62)
Month 7	3.8 (2.78)
Month 8	3.9 (2.69)
Month 9	4.1 (2.96)

Adverse Events

Time Frame	9 months plus 7 days for follow-up
Arm/Group Title	All Participants
Arm/Group Description	Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	1/439 (0.2%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	34/439 (7.7%)
Blood and lymphatic system disorders
Pancytopenia	1/439 (0.2%)
Cardiac disorders
Coranary Artery Disease	2/439 (0.5%)
Myocardial Infarction	1/439 (0.2%)
Atrial Fibrillation	1/439 (0.2%)
Gastrointestinal disorders
Pancreatitis	1/439 (0.2%)
Oesophageal Mass	1/439 (0.2%)
Abdominal Adhesions	1/439 (0.2%)
General disorders
Pain	1/439 (0.2%)
Oedema Peripheral	1/439 (0.2%)
Non-Cardiac Chest Pain	1/439 (0.2%)
Hepatobiliary disorders
Cholelithiasis	1/439 (0.2%)
Cholecystitis Acute	1/439 (0.2%)
Cholecystitis	1/439 (0.2%)
Infections and infestations
Gastroenteritis	2/439 (0.5%)
Cellulitis	2/439 (0.5%)
Pneumonia	2/439 (0.5%)
Papilloma Viral Infection	1/439 (0.2%)
Osteomyelitis	1/439 (0.2%)
Nocardiosis	1/439 (0.2%)
Meningitis Aseptic	1/439 (0.2%)
Appendicitis	1/439 (0.2%)
Abscess Limb	1/439 (0.2%)
Septic Shock	1/439 (0.2%)
Abdominal Abcess	1/439 (0.2%)
Injury, poisoning and procedural complications
Spinal Compression Fracture	1/439 (0.2%)
Road Traffic Accident	1/439 (0.2%)
Multiple Fractures	1/439 (0.2%)
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis	1/439 (0.2%)
Intervertebral Disc Protrusion	1/439 (0.2%)
Costochondritis	1/439 (0.2%)
Back Pain	1/439 (0.2%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant	1/439 (0.2%)
Nervous system disorders
Headache	1/439 (0.2%)
Dizziness	1/439 (0.2%)
Cognitive Disorder	1/439 (0.2%)
Psychiatric disorders
Mental Status Changes	1/439 (0.2%)
Depression	1/439 (0.2%)
Anxiety	1/439 (0.2%)
Renal and urinary disorders
Renal Failure Acute	1/439 (0.2%)
Respiratory, thoracic and mediastinal disorders
Respiratory Failure	2/439 (0.5%)
Pulmonary Embolism	2/439 (0.5%)
Pleural Effusion	2/439 (0.5%)
Dyspnoea	1/439 (0.2%)
Asthma	1/439 (0.2%)
Chronic Obstructive Pulmonary Disease	2/439 (0.5%)
Pulmonary Cavitation	1/439 (0.2%)
Vascular disorders
Jugular Vein Thrombosis	1/439 (0.2%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	100/439 (22.8%)
Gastrointestinal disorders
Nausea	39/439 (8.9%)
Diarrhoea	42/439 (9.6%)
Infections and infestations
Upper Respiratory Tract Infection	28/439 (6.4%)
Musculoskeletal and connective tissue disorders
Back Pain	23/439 (5.2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.