Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the bioequivalence of sprinkle and capsule formulations of lubiprostone, as compared to placebo, when administered orally in participants with Chronic Idiopathic Constipation (CIC).

Official Title
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A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo, in Adult Subjects With Chronic Idiopathic Constipation

Conditions
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Chronic Idiopathic Constipation

Intervention / Treatment
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* Drug: Lubiprostone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Either has medically-confirmed diagnosis of chronic constipation (per Rome III), or meets the diagnosis as confirmed using the Rome III constipation module questionnaire during the Screening period. Is male or female, 18 or older years of age Should be on stable dose of fiber supplement or a concomitant medication for the indication of lowering blood pressure Exclusion Criteria: Has any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation Is unable to eat or drink, take oral medications, or to hold down oral medications due to vomiting

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lubiprostone Capsule<br>Lubiprostone 24 mcg capsule twice daily (BID) for 7 days. | Drug: Lubiprostone<br>* 24 mcg administered orally BID<br>* Other names: Amitiza;|
| Experimental: Lubiprostone Sprinkle<br>Lubiprostone 24 mcg sprinkle BID for 7 days. | Drug: Lubiprostone<br>* 24 mcg administered orally BID<br>* Other names: Amitiza;|
| Placebo Comparator: Placebo<br>Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days. | Drug: Placebo<br>* 24 mcg administered orally BID<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week | Observed SBM count was based on the observed data reported in the electronic daily diary for the actual number of SBMs during the 1-week treatment period. | during the 1-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean SBM Consistency Score Within 1 Week | Stool consistency associated with SBMs was rated according to the 7-point Bristol Stool Form Scale (1-7) where 1 = Separate hard lumps, like nuts (hard to pass), 2 = Sausage-shaped but lumpy, 3 = Like a sausage but with cracks on the surface, 4 = Like a sausage or snake, smooth and soft, 5 = Soft blobs with clear-cut edges (passed easily), 6 = Fluffy pieces with ragged edges, a mushy stool, 7 = Watery, no solid pieces; entirely liquid. Scores in the mid-range of this scale indicate better stool consistency. | during the 1-week treatment period | 
| Mean SBM Straining Score Within 1 Week | Bowel straining associated with SBMs was rated on a scale of 0-4 where 0 = Absent, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Higher score indicates more straining, so a worse condition. | during the 1-week treatment period | 
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is an episode which occur after the administration of the first dose of study medication and within 7 days after final dose. | From first dose of study medication to follow-up (up to 15 days) |