Trial Outcomes & Findings for Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone (NCT NCT00620061)
NCT ID: NCT00620061
Last Updated: 2020-01-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
439 participants
Primary outcome timeframe
Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9
Results posted on
2020-01-21
Participant Flow
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)
Participant milestones
| Measure |
Lubiprostone
Lubiprostone: 24 mcg capsules twice daily (BID) for 36 weeks
|
|---|---|
|
Overall Study
STARTED
|
439
|
|
Overall Study
COMPLETED
|
286
|
|
Overall Study
NOT COMPLETED
|
153
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Opioid-induced Bowel Dysfunction: Long-Term Assessment of Lubiprostone
Baseline characteristics by cohort
| Measure |
Lubiprostone
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID) for 36 weeks
|
|---|---|
|
Age, Continuous
|
49.8 Years
STANDARD_DEVIATION 9.99 • n=93 Participants
|
|
Sex: Female, Male
Female
|
263 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
176 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
436 participants
n=93 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat population with evaluable SBM data during the given month
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.
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Month 3
|
5.0 Weekly SBMs
Standard Deviation 2.76
|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Month 4
|
5.0 Weekly SBMs
Standard Deviation 2.71
|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Month 5
|
5.0 Weekly SBMs
Standard Deviation 2.82
|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Month 6
|
5.0 Weekly SBMs
Standard Deviation 2.86
|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Baseline
|
1.4 Weekly SBMs
Standard Deviation 0.98
|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Month 1
|
4.9 Weekly SBMs
Standard Deviation 2.72
|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Month 2
|
4.9 Weekly SBMs
Standard Deviation 2.62
|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Month 7
|
5.1 Weekly SBMs
Standard Deviation 2.93
|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Month 8
|
5.3 Weekly SBMs
Standard Deviation 2.91
|
|
Mean Weekly Spontaneous Bowel Movements (SBMs) Per Month
Month 9
|
5.2 Weekly SBMs
Standard Deviation 3.19
|
PRIMARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat population with evaluable BM data during the given month
A Bowel Movement (BM) is defined as any BM (whether spontaneous or not)
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Mean Weekly Bowel Movements (BMs) Per Month
Month 3
|
5.2 Weekly BMs
Standard Deviation 2.70
|
|
Mean Weekly Bowel Movements (BMs) Per Month
Month 4
|
5.1 Weekly BMs
Standard Deviation 2.67
|
|
Mean Weekly Bowel Movements (BMs) Per Month
Month 5
|
5.1 Weekly BMs
Standard Deviation 2.79
|
|
Mean Weekly Bowel Movements (BMs) Per Month
Month 6
|
5.1 Weekly BMs
Standard Deviation 2.85
|
|
Mean Weekly Bowel Movements (BMs) Per Month
Month 7
|
5.2 Weekly BMs
Standard Deviation 2.90
|
|
Mean Weekly Bowel Movements (BMs) Per Month
Month 8
|
5.4 Weekly BMs
Standard Deviation 2.88
|
|
Mean Weekly Bowel Movements (BMs) Per Month
Month 9
|
5.3 Weekly BMs
Standard Deviation 3.15
|
|
Mean Weekly Bowel Movements (BMs) Per Month
Baseline
|
2.4 Weekly BMs
Standard Deviation 1.38
|
|
Mean Weekly Bowel Movements (BMs) Per Month
Month 1
|
5.0 Weekly BMs
Standard Deviation 2.73
|
|
Mean Weekly Bowel Movements (BMs) Per Month
Month 2
|
5.0 Weekly BMs
Standard Deviation 2.63
|
SECONDARY outcome
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat
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.
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Number of Participants Classified as Monthly Responders
Month 9
|
202 Participants
|
|
Number of Participants Classified as Monthly Responders
Month 1
|
322 Participants
|
|
Number of Participants Classified as Monthly Responders
Month 2
|
323 Participants
|
|
Number of Participants Classified as Monthly Responders
Month 3
|
291 Participants
|
|
Number of Participants Classified as Monthly Responders
Month 4
|
270 Participants
|
|
Number of Participants Classified as Monthly Responders
Month 5
|
259 Participants
|
|
Number of Participants Classified as Monthly Responders
Month 6
|
250 Participants
|
|
Number of Participants Classified as Monthly Responders
Month 7
|
239 Participants
|
|
Number of Participants Classified as Monthly Responders
Month 8
|
233 Participants
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat with evaluable data at the given time point
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.
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Straining Associated With Spontaneous Bowel Movements by Month
Baseline
|
2.7 score on a scale
Standard Deviation 0.87
|
|
Straining Associated With Spontaneous Bowel Movements by Month
Month 1
|
1.7 score on a scale
Standard Deviation 0.85
|
|
Straining Associated With Spontaneous Bowel Movements by Month
Month 2
|
1.7 score on a scale
Standard Deviation 0.85
|
|
Straining Associated With Spontaneous Bowel Movements by Month
Month 3
|
1.6 score on a scale
Standard Deviation 0.84
|
|
Straining Associated With Spontaneous Bowel Movements by Month
Month 4
|
1.7 score on a scale
Standard Deviation 0.83
|
|
Straining Associated With Spontaneous Bowel Movements by Month
Month 5
|
1.6 score on a scale
Standard Deviation 0.85
|
|
Straining Associated With Spontaneous Bowel Movements by Month
Month 6
|
1.7 score on a scale
Standard Deviation 0.84
|
|
Straining Associated With Spontaneous Bowel Movements by Month
Month 7
|
1.7 score on a scale
Standard Deviation 0.86
|
|
Straining Associated With Spontaneous Bowel Movements by Month
Month 8
|
1.6 score on a scale
Standard Deviation 0.87
|
|
Straining Associated With Spontaneous Bowel Movements by Month
Month 9
|
1.6 score on a scale
Standard Deviation 0.92
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat with evaluable data at the given time point
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.
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Baseline
|
3.0 score on a scale
Standard Deviation 0.84
|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Month 1
|
2.3 score on a scale
Standard Deviation 0.75
|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Month 2
|
2.2 score on a scale
Standard Deviation 0.73
|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Month 3
|
2.2 score on a scale
Standard Deviation 0.74
|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Month 4
|
2.2 score on a scale
Standard Deviation 0.72
|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Month 5
|
2.2 score on a scale
Standard Deviation 0.70
|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Month 6
|
2.2 score on a scale
Standard Deviation 0.68
|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Month 7
|
2.2 score on a scale
Standard Deviation 0.70
|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Month 8
|
2.2 score on a scale
Standard Deviation 0.66
|
|
Stool Consistency of Spontaneous Bowel Movements by Month
Month 9
|
2.2 score on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat with evaluable scores at the given time point
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.
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Constipation Severity by Month
Month 9
|
1.4 score on a scale
Standard Deviation 0.99
|
|
Constipation Severity by Month
Baseline
|
2.4 score on a scale
Standard Deviation 0.72
|
|
Constipation Severity by Month
Month 1
|
1.5 score on a scale
Standard Deviation 0.93
|
|
Constipation Severity by Month
Month 2
|
1.5 score on a scale
Standard Deviation 0.94
|
|
Constipation Severity by Month
Month 3
|
1.5 score on a scale
Standard Deviation 0.93
|
|
Constipation Severity by Month
Month 4
|
1.5 score on a scale
Standard Deviation 0.96
|
|
Constipation Severity by Month
Month 5
|
1.4 score on a scale
Standard Deviation 0.95
|
|
Constipation Severity by Month
Month 6
|
1.4 score on a scale
Standard Deviation 0.94
|
|
Constipation Severity by Month
Month 7
|
1.4 score on a scale
Standard Deviation 0.94
|
|
Constipation Severity by Month
Month 8
|
1.4 score on a scale
Standard Deviation 0.97
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat with evaluable data at the given time point
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.
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Abdominal Bloating by Month
Month 4
|
1.5 score on a scale
Standard Deviation 0.90
|
|
Abdominal Bloating by Month
Month 5
|
1.5 score on a scale
Standard Deviation 0.92
|
|
Abdominal Bloating by Month
Month 7
|
1.5 score on a scale
Standard Deviation 0.93
|
|
Abdominal Bloating by Month
Month 8
|
1.5 score on a scale
Standard Deviation 0.95
|
|
Abdominal Bloating by Month
Baseline
|
2.2 score on a scale
Standard Deviation 0.74
|
|
Abdominal Bloating by Month
Month 1
|
1.6 score on a scale
Standard Deviation 0.88
|
|
Abdominal Bloating by Month
Month 2
|
1.5 score on a scale
Standard Deviation 0.90
|
|
Abdominal Bloating by Month
Month 3
|
1.5 score on a scale
Standard Deviation 0.91
|
|
Abdominal Bloating by Month
Month 6
|
1.5 score on a scale
Standard Deviation 0.91
|
|
Abdominal Bloating by Month
Month 9
|
1.5 score on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat with evaluable data at the given time point
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.
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Abdominal Discomfort by Month
Month 2
|
1.4 score on a scale
Standard Deviation 0.82
|
|
Abdominal Discomfort by Month
Month 3
|
1.4 score on a scale
Standard Deviation 0.84
|
|
Abdominal Discomfort by Month
Month 4
|
1.4 score on a scale
Standard Deviation 0.83
|
|
Abdominal Discomfort by Month
Month 5
|
1.4 score on a scale
Standard Deviation 0.86
|
|
Abdominal Discomfort by Month
Baseline
|
2.2 score on a scale
Standard Deviation 0.67
|
|
Abdominal Discomfort by Month
Month 1
|
1.5 score on a scale
Standard Deviation 0.82
|
|
Abdominal Discomfort by Month
Month 6
|
1.4 score on a scale
Standard Deviation 0.85
|
|
Abdominal Discomfort by Month
Month 7
|
1.4 score on a scale
Standard Deviation 0.85
|
|
Abdominal Discomfort by Month
Month 8
|
1.4 score on a scale
Standard Deviation 0.89
|
|
Abdominal Discomfort by Month
Month 9
|
1.4 score on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat with evaluable data at the given time point
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.
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Bowel Habit Regularity by Month
Baseline
|
4.7 score on a scale
Standard Deviation 1.59
|
|
Bowel Habit Regularity by Month
Month 1
|
3.6 score on a scale
Standard Deviation 1.39
|
|
Bowel Habit Regularity by Month
Month 2
|
3.6 score on a scale
Standard Deviation 1.38
|
|
Bowel Habit Regularity by Month
Month 3
|
3.5 score on a scale
Standard Deviation 1.42
|
|
Bowel Habit Regularity by Month
Month 4
|
3.5 score on a scale
Standard Deviation 1.45
|
|
Bowel Habit Regularity by Month
Month 5
|
3.5 score on a scale
Standard Deviation 1.47
|
|
Bowel Habit Regularity by Month
Month 6
|
3.5 score on a scale
Standard Deviation 1.50
|
|
Bowel Habit Regularity by Month
Month 7
|
3.5 score on a scale
Standard Deviation 1.47
|
|
Bowel Habit Regularity by Month
Month 8
|
3.4 score on a scale
Standard Deviation 1.49
|
|
Bowel Habit Regularity by Month
Month 9
|
3.4 score on a scale
Standard Deviation 1.51
|
SECONDARY outcome
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat with evaluable data at the given time point
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.
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Treatment Effectiveness by Month
Month 8
|
2.3 score on a scale
Standard Deviation 1.08
|
|
Treatment Effectiveness by Month
Month 9
|
2.3 score on a scale
Standard Deviation 1.09
|
|
Treatment Effectiveness by Month
Month 1
|
2.1 score on a scale
Standard Deviation 0.98
|
|
Treatment Effectiveness by Month
Month 2
|
2.1 score on a scale
Standard Deviation 1.02
|
|
Treatment Effectiveness by Month
Month 3
|
2.2 score on a scale
Standard Deviation 1.04
|
|
Treatment Effectiveness by Month
Month 4
|
2.2 score on a scale
Standard Deviation 1.05
|
|
Treatment Effectiveness by Month
Month 5
|
2.2 score on a scale
Standard Deviation 1.05
|
|
Treatment Effectiveness by Month
Month 6
|
2.2 score on a scale
Standard Deviation 1.04
|
|
Treatment Effectiveness by Month
Month 7
|
2.3 score on a scale
Standard Deviation 1.05
|
SECONDARY outcome
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat with evaluable data at the time point
Participants rate each SBM as complete if their bowels feel completely empty after the SBM
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Mean Weekly Complete SBMs by Month
Month 1
|
3.1 Weekly Complete SBMs
Standard Deviation 2.26
|
|
Mean Weekly Complete SBMs by Month
Month 2
|
3.4 Weekly Complete SBMs
Standard Deviation 2.27
|
|
Mean Weekly Complete SBMs by Month
Month 3
|
3.6 Weekly Complete SBMs
Standard Deviation 2.47
|
|
Mean Weekly Complete SBMs by Month
Month 8
|
3.9 Weekly Complete SBMs
Standard Deviation 2.69
|
|
Mean Weekly Complete SBMs by Month
Month 9
|
4.2 Weekly Complete SBMs
Standard Deviation 2.95
|
|
Mean Weekly Complete SBMs by Month
Month 4
|
3.6 Weekly Complete SBMs
Standard Deviation 2.40
|
|
Mean Weekly Complete SBMs by Month
Month 5
|
3.7 Weekly Complete SBMs
Standard Deviation 2.64
|
|
Mean Weekly Complete SBMs by Month
Month 6
|
3.7 Weekly Complete SBMs
Standard Deviation 2.62
|
|
Mean Weekly Complete SBMs by Month
Month 7
|
3.9 Weekly Complete SBMs
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: Months 1, 2, 3, 4, 5, 6, 7, 8, and 9Population: Intent-to-treat with evaluable data at the time point
Participants rate each BM as complete if their bowels feel completely empty after the BM
Outcome measures
| Measure |
All Participants
n=439 Participants
Lubiprostone: 24 mcg capsules twice daily (BID)
|
|---|---|
|
Mean Weekly Complete BMs by Month
Month 1
|
3.1 Weekly Complete BMs
Standard Deviation 2.26
|
|
Mean Weekly Complete BMs by Month
Month 2
|
3.4 Weekly Complete BMs
Standard Deviation 2.28
|
|
Mean Weekly Complete BMs by Month
Month 3
|
3.6 Weekly Complete BMs
Standard Deviation 2.46
|
|
Mean Weekly Complete BMs by Month
Month 4
|
3.7 Weekly Complete BMs
Standard Deviation 2.38
|
|
Mean Weekly Complete BMs by Month
Month 5
|
3.8 Weekly Complete BMs
Standard Deviation 2.65
|
|
Mean Weekly Complete BMs by Month
Month 6
|
3.8 Weekly Complete BMs
Standard Deviation 2.62
|
|
Mean Weekly Complete BMs by Month
Month 7
|
3.8 Weekly Complete BMs
Standard Deviation 2.78
|
|
Mean Weekly Complete BMs by Month
Month 8
|
3.9 Weekly Complete BMs
Standard Deviation 2.69
|
|
Mean Weekly Complete BMs by Month
Month 9
|
4.1 Weekly Complete BMs
Standard Deviation 2.96
|
Adverse Events
All Participants
Serious events: 34 serious events
Other events: 100 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
All Participants
n=439 participants at risk
Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
|
|---|---|
|
Infections and infestations
Gastroenteritis
|
0.46%
2/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Cellulitis
|
0.46%
2/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Pneumonia
|
0.46%
2/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Papilloma Viral Infection
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Osteomyelitis
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Nocardiosis
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Meningitis Aseptic
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Appendicitis
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Abscess Limb
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Septic Shock
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Abdominal Abcess
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.46%
2/439 • 9 months plus 7 days for follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.46%
2/439 • 9 months plus 7 days for follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.46%
2/439 • 9 months plus 7 days for follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Cardiac disorders
Coranary Artery Disease
|
0.46%
2/439 • 9 months plus 7 days for follow-up
|
|
Cardiac disorders
Myocardial Infarction
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Cardiac disorders
Atrial Fibrillation
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
General disorders
Pain
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
General disorders
Oedema Peripheral
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
General disorders
Non-Cardiac Chest Pain
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Gastrointestinal disorders
Pancreatitis
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Gastrointestinal disorders
Oesophageal Mass
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Gastrointestinal disorders
Abdominal Adhesions
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Psychiatric disorders
Mental Status Changes
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Psychiatric disorders
Depression
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Psychiatric disorders
Anxiety
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Nervous system disorders
Headache
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Nervous system disorders
Dizziness
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Nervous system disorders
Cognitive Disorder
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Hepatobiliary disorders
Cholecystitis
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.46%
2/439 • 9 months plus 7 days for follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Cavitation
|
0.23%
1/439 • 9 months plus 7 days for follow-up
|
Other adverse events
| Measure |
All Participants
n=439 participants at risk
Lubiprostone: 24 mcg capsules twice daily (BID) for 9 months
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
8.9%
39/439 • 9 months plus 7 days for follow-up
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
42/439 • 9 months plus 7 days for follow-up
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.4%
28/439 • 9 months plus 7 days for follow-up
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.2%
23/439 • 9 months plus 7 days for follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60