Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome (NCT NCT02544152)

Last Updated: 2019-12-27

Results Overview

An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

71 participants

Primary outcome timeframe

within 12 weeks

Results posted on

2019-12-27

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone Participants receive 8 mcg lubiprostone capsules BID
Overall Study STARTED	34	37
Overall Study Modified Intent to Treat (mITT)	34	37
Overall Study Safety Analysis Set (SAS)	34	37
Overall Study COMPLETED	33	30
Overall Study NOT COMPLETED	1	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone Participants receive 8 mcg lubiprostone capsules BID
Overall Study Adverse Event	0	4
Overall Study Withdrawal by Subject	0	3
Overall Study Other	1	0

Baseline Characteristics

Evaluation of the Efficacy and Safety of Lubiprostone in Adults With Mixed or Unsubtyped Irritable Bowel Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	45 years n=5 Participants	49 years n=7 Participants	48 years n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	32 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	33 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants	37 participants n=7 Participants	71 participants n=5 Participants
Baseline Abdominal Pain	5.90 units on a scale STANDARD_DEVIATION 1.340 • n=5 Participants	5.37 units on a scale STANDARD_DEVIATION 1.406 • n=7 Participants	5.62 units on a scale STANDARD_DEVIATION 1.390 • n=5 Participants

PRIMARY outcome

Timeframe: within 12 weeks

Population: modified Intent to Treat (mITT), defined as all randomized subjects who take at least one dose of study medication.

An overall responder for abdominal pain is defined as a participant who is a weekly responder for at least 75% of observed treatment weeks.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID
Number of Participants Classified as an Overall Responder for Abdominal Pain	10 Participants	11 Participants

SECONDARY outcome

Timeframe: within 12 weeks

Population: mITT

Participants rate their pain on a pain intensity scale where 0=no pain and 10=worst pain. A higher score means the pain is worse. A weekly responder for abdominal pain is defined as a participant reporting ≥ 30% reduction from baseline in average of 24-hour worst abdominal pain scores for the preceding week.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 1	7 Participants	7 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 2	13 Participants	8 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 3	11 Participants	12 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 4	13 Participants	19 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 5	15 Participants	18 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 6	16 Participants	15 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 7	14 Participants	14 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 8	11 Participants	18 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 9	13 Participants	15 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 10	15 Participants	12 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 11	14 Participants	14 Participants
Number of Participants Classified as a Weekly Responder for Abdominal Pain Week 12	10 Participants	12 Participants

SECONDARY outcome

Timeframe: within 3 months

Population: mITT

A monthly responder for abdominal pain is defined as a participant who is a weekly responder for abdominal pain at least 2 of 4 weeks in the preceding month.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID
Number of Participants Classified as a Monthly Responder for Abdominal Pain Month 1	12 Participants	14 Participants
Number of Participants Classified as a Monthly Responder for Abdominal Pain Month 2	16 Participants	16 Participants
Number of Participants Classified as a Monthly Responder for Abdominal Pain Month 3	15 Participants	13 Participants

SECONDARY outcome

Timeframe: within 12 weeks

Population: mITT

A weekly responder for stool consistency is defined as a participant having at least 50% reduction from baseline in percentage of days with extreme stool consistency for a given week.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 1	5 Participants	12 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 2	6 Participants	11 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 3	5 Participants	10 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 4	7 Participants	10 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 5	11 Participants	9 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 6	8 Participants	7 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 7	8 Participants	9 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 8	6 Participants	9 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 9	6 Participants	5 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 10	8 Participants	10 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 11	7 Participants	6 Participants
Number of Participants Classified as a Weekly Responder for Stool Consistency Week 12	8 Participants	8 Participants

SECONDARY outcome

Timeframe: within 3 months

Population: mITT

A monthly responder for stool consistency is defined as a participant who is a weekly responder for stool consistency at least 2 of 4 weeks in the preceding month.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID
Number of Participants Classified as a Monthly Responder for Stool Consistency Month 1	3 Participants	12 Participants
Number of Participants Classified as a Monthly Responder for Stool Consistency Month 2	12 Participants	9 Participants
Number of Participants Classified as a Monthly Responder for Stool Consistency Month 3	7 Participants	7 Participants

SECONDARY outcome

Timeframe: within 3 months

Population: mITT

An overall responder for stool consistency is defined as a participant who qualifies as a weekly responder for stool consistency for at least 75% of observed treatment weeks.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID
Number of Participants Classified as an Overall Responder for Stool Consistency	0 Participants	3 Participants

SECONDARY outcome

Timeframe: within 12 weeks

Population: mITT

A participant who achieves adequate relief of IBS symptoms during the preceding week is classified as a weekly responder for IBS symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 1	14 Participants	9 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 2	16 Participants	14 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 3	18 Participants	15 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 4	21 Participants	20 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 5	22 Participants	19 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 6	19 Participants	17 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 7	16 Participants	17 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 8	17 Participants	20 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 9	18 Participants	14 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 10	15 Participants	15 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 11	18 Participants	14 Participants
Number of Participants Classified as a Weekly Responder for Irritable Bowel Syndrome (IBS) Symptoms Week 12	4 Participants	6 Participants

SECONDARY outcome

Timeframe: within 3 months

Population: mITT

A participant who is a weekly responder for IBS symptoms for at least 2 of the 4 weeks in the preceding month is classified as a monthly responder for IBS symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID
Number of Participants Classified as a Monthly Responder for IBS Symptoms Month 1	21 Participants	16 Participants
Number of Participants Classified as a Monthly Responder for IBS Symptoms Month 2	20 Participants	18 Participants
Number of Participants Classified as a Monthly Responder for IBS Symptoms Month 3	17 Participants	15 Participants

SECONDARY outcome

Timeframe: within 3 months

Population: mITT

A participant who is a weekly responder for IBS symptoms for at least 75% of observed treatment weeks is classified as an overall responder for IBS symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=34 Participants Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 Participants Participants receive 8 mcg lubiprostone capsules BID
Number of Participants Classified as an Overall Responder for IBS Symptoms	11 Participants	10 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Lubiprostone

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=34 participants at risk Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 participants at risk Participants receive 8 mcg lubiprostone capsules BID
Gastrointestinal disorders Colitis	0.00% 0/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.

Other adverse events

Additional Information

Medical Information Call Center

Mallinckrodt

Phone: 800-556-3314

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Placebo n=34 participants at risk Participants receive 0 mcg capsules twice daily (BID)	Lubiprostone n=37 participants at risk Participants receive 8 mcg lubiprostone capsules BID
Endocrine disorders Diabetic retinal oedema	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Gastrointestinal disorders Nausea	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	5.4% 2/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Gastrointestinal disorders Abdominal pain	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Gastrointestinal disorders Colitis	0.00% 0/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Gastrointestinal disorders Diarrhoea	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Gastrointestinal disorders Dyspepsia	0.00% 0/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Gastrointestinal disorders Vomiting	0.00% 0/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Hepatobiliary disorders Cholecystitis chronic	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Hepatobiliary disorders Cholelithiasis	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Infections and infestations Urinary tract infection	0.00% 0/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	10.8% 4/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Infections and infestations Viral infection	0.00% 0/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Infections and infestations Ear infection	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Infections and infestations Influenza	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Infections and infestations Mastitis	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Infections and infestations Sinusitis	5.9% 2/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Investigations Mean cell volume increased	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Psychiatric disorders Anxiety	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	2.7% 1/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Respiratory, thoracic and mediastinal disorders Asthma	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.
Surgical and medical procedures Cholecystectomy	2.9% 1/34 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.	0.00% 0/37 • 13 weeks Treatment-emergent adverse events, defined as any event with an onset date that is on or after the first dose of study medication and with an onset date no more than 7 days after the last dose of study medication.