Trial Outcomes & Findings for Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation. (NCT NCT01190020)

Results Overview

Change in the mean area under the curve of the breath hydrogen and methane gas profiles in parts per million, from time 0 to 120 minutes, between baseline versus mean area under the curve at the end of study.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

Baseline and 1 month

Results posted on

2019-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	Lubiprostone Received 24 mcg of lubiprostone twice a day with meals.	Placebo Received placebo twice a day with meals.
Overall Study STARTED	29	12
Overall Study COMPLETED	22	12
Overall Study NOT COMPLETED	7	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Lubiprostone Received 24 mcg of lubiprostone twice a day with meals.	Placebo Received placebo twice a day with meals.
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	2	0
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lubiprostone n=29 Participants	Placebo n=12 Participants	Total n=41 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	26 Participants n=5 Participants	11 Participants n=7 Participants	37 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Continuous	42.8 years STANDARD_DEVIATION 11.9 • n=5 Participants	47.3 years STANDARD_DEVIATION 22.5 • n=7 Participants	43.7 years STANDARD_DEVIATION 13.7 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	12 Participants n=7 Participants	37 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	12 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 1 month

Population: patients who completed the study were analyzed

Change in the mean area under the curve of the breath hydrogen and methane gas profiles in parts per million, from time 0 to 120 minutes, between baseline versus mean area under the curve at the end of study.

Outcome measures

Outcome measures
Measure	Lubiprostone n=22 Participants	Placebo n=12 Participants
Change in Methane Production	10645 parts per million*minutes Standard Error 1481	14635 parts per million*minutes Standard Error 2330

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: subjects who completed the study

change in mean stool frequency (delta) between baseline week and final week of study

Outcome measures

Outcome measures
Measure	Lubiprostone n=22 Participants	Placebo n=12 Participants
Stool Frequency (Complete Spontaneous Bowel Movements)	3.71 bowel movements per week Standard Error 0.84	0.85 bowel movements per week Standard Error 0.54

SECONDARY outcome

Timeframe: Baseline and 1 month

Population: subjects who completed the study

Percentage change of colonic transit time between the baseline colonic transit study and the colonic transit study at the end of study

Outcome measures

Outcome measures
Measure	Lubiprostone n=22 Participants	Placebo n=12 Participants
Percentage Change in the Colonic Transit Time	0.23 percent Standard Error 0.06	0.48 percent Standard Error 0.1

SECONDARY outcome

Timeframe: Baseline and 1 month

The peak methane value measured during the baseline breath study will be compared with the peak methane obtained at the end of study breath test

Outcome measures

Outcome measures
Measure	Lubiprostone n=22 Participants	Placebo n=12 Participants
Peak Methane Value	51.3 parts per million Standard Error 7.1	70.5 parts per million Standard Error 11.2

Adverse Events

Lubiprostone

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lubiprostone n=29 participants at risk	Placebo n=12 participants at risk
Respiratory, thoracic and mediastinal disorders Chest Tightness	6.9% 2/29	0.00% 0/12
Respiratory, thoracic and mediastinal disorders Shortness of Breath	6.9% 2/29	0.00% 0/12

Additional Information

Robert Summers, MD

University of Iowa

Phone: 319-356-2130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place