Trial Outcomes & Findings for Lubiprostone as a Treatment for Constipation in Parkinson's Disease (NCT NCT00669461)

Results Overview

The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

up to 6 weeks

Results posted on

2016-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Lubiprostone patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lubiprostone as a Treatment for Constipation in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lubiprostone n=1 Participants patient received treatment( lubiprostone)24 mcg po BID for 4 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	73 years STANDARD_DEVIATION 0 • n=5 Participants
Gender Female	0 Participants n=5 Participants
Gender Male	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 weeks

Population: Analysis was not performed for this outcome measure secondary to the small sample size ( one patient)

The average BSFS will be determined at baseline (prior to the start lubiprostone) and compared with average rating of BSFS at end of the 4 weeks of treatment with Lubiprostone and at end of 2 weeks after stopping the Lubiprostone. BSFS is scale between 1-7, it measured the shape of the stool. BSFS is a scale between 1-7, where 1 correlates with the firmest stool and 7 correlates with entirely liquid stool. Measure was reported at end of week #1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 6 weeks

Population: Analysis was not performed for this outcome measure secondary to the small sample size ( one patient.

Average number of spontaneous bowel movements (SBM) per week,measured at baseline, at end of 4 weeks of treatment with Lubiprostone and at 2 weeks after stopping Lubiprostone (( so measure was reported at end of week # 1-Baseline-,end of Week #5 ( after taking the lubiprostone for 4 weeks) and end of week # 7 ( end of 2 weeks after stopping the Lubiprostone)).

Outcome measures

Outcome data not reported

Adverse Events

Lubiprostone

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

Muhannad Heif, MD

University of Arkansas for Medical Sciences

Phone: 5016500215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place