Trial Outcomes & Findings for Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation (NCT NCT01993875)

NCT ID: NCT01993875

Last Updated: 2019-12-13

Results Overview

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

164 participants

Primary outcome timeframe

within 1 week

Results posted on

2019-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	Lubiprostone Participants received liquid formulation of Lubiprostone drug, 12 microgram (mcg) x 2 pumps administered orally twice daily (BID).	Placebo Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Overall Study STARTED	82	82
Overall Study COMPLETED	75	76
Overall Study NOT COMPLETED	7	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lubiprostone n=82 Participants Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.	Placebo n=82 Participants Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.	Total n=164 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	78 Participants n=5 Participants	75 Participants n=7 Participants	153 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Age, Continuous	47.2 years STANDARD_DEVIATION 12.51 • n=5 Participants	45.0 years STANDARD_DEVIATION 12.82 • n=7 Participants	46.1 years STANDARD_DEVIATION 12.68 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants	58 Participants n=7 Participants	113 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants	29 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=5 Participants	53 Participants n=7 Participants	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 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	42 Participants n=5 Participants	38 Participants n=7 Participants	80 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	40 Participants n=7 Participants	78 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	82 participants n=5 Participants	82 participants n=7 Participants	164 participants n=5 Participants
Body mass index	29.5 kg/m^2 STANDARD_DEVIATION 5.03 • n=5 Participants	30.9 kg/m^2 STANDARD_DEVIATION 6.50 • n=7 Participants	30.2 kg/m^2 STANDARD_DEVIATION 5.84 • n=5 Participants
Previous AMITIZA use at randomization No	80 Participants n=5 Participants	81 Participants n=7 Participants	161 Participants n=5 Participants
Previous AMITIZA use at randomization Yes	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: within 1 week

Population: Modified Intention to Treat (mITT), defined as all participants who received at least 1 dose of study medication.

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

Outcome measures
Measure	Lubiprostone n=82 Participants Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.	Placebo n=82 Participants Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Number of Spontaneous Bowel Movements (SBMs) Within 1 Week	4.6 number of SBMs Standard Deviation 3.33	4.0 number of SBMs Standard Deviation 3.50

SECONDARY outcome

Timeframe: at Week 1

Population: mITT Population

Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.

Outcome measures

Outcome measures
Measure	Lubiprostone n=82 Participants Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.	Placebo n=82 Participants Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Consistency of SBMs at Week 1	3.2 score on a scale Standard Deviation 3.12	2.4 score on a scale Standard Deviation 3.38

SECONDARY outcome

Timeframe: at Week 1

Population: mITT Population

Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.

Outcome measures

Outcome measures
Measure	Lubiprostone n=82 Participants Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.	Placebo n=82 Participants Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Overall Stool Consistency at Week 1	3.3 score on a scale Standard Deviation 1.38	3.0 score on a scale Standard Deviation 1.17

SECONDARY outcome

Timeframe: Baseline and Week 1

Population: mITT Population

Outcome measures

Outcome measures
Measure	Lubiprostone n=82 Participants Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.	Placebo n=82 Participants Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Mean Change From Baseline in Stool Consistency at Week 1	1.8 Units on a scale Standard Deviation 0.91	1.9 Units on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Week 1

Population: mITT Population

Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).

Outcome measures

Outcome measures
Measure	Lubiprostone n=82 Participants Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.	Placebo n=82 Participants Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Overall Straining at Week 1	1.8 Units on a scale Standard Deviation 0.91	1.9 Units on a scale Standard Deviation 0.81

SECONDARY outcome

Timeframe: Week 1

Population: mITT Population

Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The change from baseline was calculated as post-treatment value minus the baseline value.

Outcome measures

Outcome measures
Measure	Lubiprostone n=82 Participants Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.	Placebo n=82 Participants Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Mean Change From Baseline in Straining at Week 1	-1.1 Units on a scale Standard Deviation 0.94	-0.8 Units on a scale Standard Deviation 0.82

Adverse Events

Lubiprostone

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lubiprostone n=82 participants at risk Participants received liquid formulation of Lubiprostone drug, 12 mcg x 2 pumps administered orally BID.	Placebo n=82 participants at risk Participants received placebo matching the liquid formulation of Lubiprostone drug via pump administered orally BID.
Gastrointestinal disorders Nausea	11.0% 9/82 • Up to 7 Weeks	1.2% 1/82 • Up to 7 Weeks
Gastrointestinal disorders Flatulence	8.5% 7/82 • Up to 7 Weeks	7.3% 6/82 • Up to 7 Weeks
Gastrointestinal disorders Abdominal distension	1.2% 1/82 • Up to 7 Weeks	3.7% 3/82 • Up to 7 Weeks
Gastrointestinal disorders Abdominal pain	1.2% 1/82 • Up to 7 Weeks	3.7% 3/82 • Up to 7 Weeks
Infections and infestations Upper respiratory tract infection	2.4% 2/82 • Up to 7 Weeks	0.00% 0/82 • Up to 7 Weeks
Nervous system disorders Headache	7.3% 6/82 • Up to 7 Weeks	11.0% 9/82 • Up to 7 Weeks
Nervous system disorders Presyncope	6.1% 5/82 • Up to 7 Weeks	0.00% 0/82 • Up to 7 Weeks
Nervous system disorders Dizziness	2.4% 2/82 • Up to 7 Weeks	0.00% 0/82 • Up to 7 Weeks
Respiratory, thoracic and mediastinal disorders Throat irritation	2.4% 2/82 • Up to 7 Weeks	0.00% 0/82 • Up to 7 Weeks

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