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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: Lubiprostone; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 164
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Anniston, Alabama, United States, 36207
  • California
    • Anaheim, California, United States, 92801
  • Florida
    • DeLand, Florida, United States, 32720
    • Hollywood, Florida, United States, 33024
    • Orlando, Florida, United States, 32809
    • South Miami, Florida, United States, 33143
  • Kansas
    • Overland Park, Kansas, United States, 66212
  • New Jersey
    • Marlton, New Jersey, United States, 08053
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
  • Utah
    • Salt Lake City, Utah, United States, 84106
  • Wisconsin
    • West Bend, Wisconsin, United States, 53095

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
Experimental: Lubiprostone	Drug: Lubiprostone; Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	within 1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	at Week 1
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.	at Week 1
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).	Baseline and Week 1
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).	Week 1
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.	Week 1

Collaborators and Investigators

• Sponsor: Mallinckrodt
• Collaborators: Takeda; Sucampo Pharma Americas, LLC; Sucampo AG

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 19, 2013
• First Submitted That Met QC Criteria: November 22, 2013
• First Posted (Estimate): November 25, 2013

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Membrane Transport Modulators; Chloride Channel Agonists; Lubiprostone
• Other Study ID Numbers: SCMP-0211-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO