Back to resultsPharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Primary Purpose
Chronic Idiopathic Constipation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lubiprostone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Idiopathic Constipation
Eligibility Criteria
Inclusion Criteria:
- Medically-confirmed diagnosis of chronic idiopathic constipation
- Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
- Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors
Exclusion Criteria:
- Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
- Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lubiprostone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
Secondary Outcome Measures
Consistency of SBMs at Week 1
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.
Overall Stool Consistency at Week 1
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.
Mean Change From Baseline in Stool Consistency at Week 1
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. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean).
Overall Straining at Week 1
Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).
Mean Change From Baseline in Straining at Week 1
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.
Full Information
NCT ID
NCT01993875
First Posted
November 19, 2013
Last Updated
November 26, 2019
Sponsor
Mallinckrodt
Collaborators
Sucampo Pharma Americas, LLC, Takeda, Sucampo AG
1. Study Identification
Unique Protocol Identification Number
NCT01993875
Brief Title
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Official Title
A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
Collaborators
Sucampo Pharma Americas, LLC, Takeda, Sucampo AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lubiprostone
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Intervention Description
Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
Primary Outcome Measure Information:
Title
Number of Spontaneous Bowel Movements (SBMs) Within 1 Week
Description
SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.
Time Frame
within 1 week
Secondary Outcome Measure Information:
Title
Consistency of SBMs at Week 1
Description
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.
Time Frame
at Week 1
Title
Overall Stool Consistency at Week 1
Description
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.
Time Frame
at Week 1
Title
Mean Change From Baseline in Stool Consistency at Week 1
Description
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. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean).
Time Frame
Baseline and Week 1
Title
Overall Straining at Week 1
Description
Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).
Time Frame
Week 1
Title
Mean Change From Baseline in Straining at Week 1
Description
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.
Time Frame
Week 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Medically-confirmed diagnosis of chronic idiopathic constipation
Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors
Exclusion Criteria:
Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
City
West Bend
State/Province
Wisconsin
ZIP/Postal Code
53095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
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