Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Drug: Placebo
- Registration Number
- NCT03097861
- Lead Sponsor
- Sucampo Pharma Americas, LLC
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 552
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days. Lubiprostone Capsule Lubiprostone Lubiprostone 24 mcg capsule twice daily (BID) for 7 days. Lubiprostone Sprinkle Lubiprostone Lubiprostone 24 mcg sprinkle BID for 7 days.
- Primary Outcome Measures
Name Time Method Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week during the 1-week treatment period 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.
- Secondary Outcome Measures
Name Time Method Mean SBM Straining Score Within 1 Week during the 1-week treatment period 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.
Mean SBM Consistency Score Within 1 Week during the 1-week treatment period 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.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) From first dose of study medication to follow-up (up to 15 days) 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.
Trial Locations
- Locations (3)
Investigative Site
🇺🇸Richmond, Virginia, United States
Investigative Sitee
🇺🇸High Point, North Carolina, United States
Investigative Site 2
🇺🇸Jackson, Tennessee, United States