Phase 3
N=164
Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Chronic Idiopathic Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01993875 ↗Enrolled (actual)
164
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Number of Spontaneous Bowel Movements (SBMs) Within 1 Week — 4.6; 4.0 number of SBMs — p=0.1290
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Lubiprostone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mallinckrodt
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Spontaneous Bowel Movements (SBMs) Within 1 Week |
4.6; 4.0 | 0.1290 |
| SECONDARY Consistency of SBMs at Week 1 |
3.2; 2.4 | 0.1290 |
| SECONDARY Overall Stool Consistency at Week 1 |
3.3; 3.0 | 0.2177 |
| SECONDARY Mean Change From Baseline in Stool Consistency at Week 1 |
1.8; 1.9 | 0.2177 |
| SECONDARY Overall Straining at Week 1 |
1.8; 1.9 | 0.0664 |
| SECONDARY Mean Change From Baseline in Straining at Week 1 |
-1.1; -0.8 | 0.0664 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01993875). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.