Trial Outcomes & Findings for Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications (NCT NCT01096290)

Results Overview

Subjects will report symptoms by questionnaire

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

30 days

Results posted on

2020-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	Lubiprostone 24mcg BID for 30 Days Active medication lubiprostone: 24mcg BID, capsule, oral 30days	Placebo Placebo, matched, blinded Matched placebo: Twice daily for 30days, oral
Overall Study STARTED	9	14
Overall Study COMPLETED	9	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Lubiprostone and Placebo for the Relief of Constipation From Constipating Medications

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lubiprostone 24mcg BID for 30 Days n=9 Participants Active medication lubiprostone: 24mcg BID, capsule, oral 30days	Placebo n=14 Participants Placebo, matched, blinded Matched placebo: Twice daily for 30days, oral	Total n=23 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	8 Participants n=5 Participants	12 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Subjects will report symptoms by questionnaire

Outcome measures

Outcome measures
Measure	Lubiprostone 24mcg BID for 30 Days n=9 Participants Active medication lubiprostone: 24mcg BID, capsule, oral 30days	Placebo n=14 Participants Placebo, matched, blinded Matched placebo: Twice daily for 30days, oral
Relief of Constipation Defined by Modified ROME Criteria	7 Participants	7 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Data was not collected for this Outcome Measure

Subjects will report stool frequency by questionnaire

Outcome measures

Outcome data not reported

Adverse Events

Lubiprostone 24mcg BID for 30 Days

Serious events: 0 serious events

Other events: 0 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

Adverse event data not reported

Additional Information

Jack DiPalma, MD

University of South Alabama

Phone: 251-660-5555

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place