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

Chronic Idiopathic Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097861
• Other study ID #: SCMP-0211-302
• Status: Completed
• Phase: Phase 3
• Start date: March 13, 2017
• Est. completion date: August 17, 2017

Study information

• Verified date: January 2020
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: August 17, 2017
• Est. primary completion date: August 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• Lubiprostone
24 mcg administered orally BID
• Placebo
24 mcg administered orally BID

Locations

Country	Name	City	State
United States	Investigative Site	Anaheim	California
United States	Investigative Site	Athens	Georgia
United States	Investigative Sitee	Bellevue	Nebraska
United States	Investigative Site	Birmingham	Alabama
United States	Investigative Site	Blackfoot	Idaho
United States	Investigative Site	Boise	Idaho
United States	Investigative Site	Bronx	New York
United States	Investigative Site	Charleston	South Carolina
United States	Investigative Site	Chattanooga	Tennessee
United States	Investigative Site	Chevy Chase	Maryland
United States	Investigative Sitee	Chula Vista	California
United States	Investigative Site	Clearwater	Florida
United States	Investigative Site	Cleveland	Ohio
United States	Investigative Site	Colorado Springs	Colorado
United States	Investigative Site	Coral Springs	Florida
United States	Investigative Site	DeLand	Florida
United States	Investigative Site	Foley	Alabama
United States	Investigative Site	Garden Grove	California
United States	Investigative Site	Hagerstown	Maryland
United States	Investigative Site	Hialeah	Florida
United States	Investigative Sitee	High Point	North Carolina
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Houston	Texas
United States	Investigative Site	Jackson	Missouri
United States	Investigative Site	Jackson	Tennessee
United States	Investigative Site 2	Jackson	Tennessee
United States	Investigative Site	Jupiter	Florida
United States	Investigative Site	Lake Charles	Louisiana
United States	Investigative Site	Las Vegas	Nevada
United States	Investigative Site	Layton	Utah
United States	Investigative Site	Little Rock	Arkansas
United States	Investigative Site	Long Beach	California
United States	Investigative Site	Longview	Texas
United States	Investigative Site	Los Angeles	California
United States	Investigative Site	McAllen	Texas
United States	Investigative Site	Mentor	Ohio
United States	Investigative Site	Meridian	Idaho
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Miami	Florida
United States	Investigative Site 2	Miami	Florida
United States	Investigative Site	Midwest City	Oklahoma
United States	Investigative Site	New Bedford	Massachusetts
United States	Investigative Site	New London	Connecticut
United States	Investigative Site	New Orleans	Louisiana
United States	Investigative Site	Newport News	Virginia
United States	Investigative Site	Orlando	Florida
United States	Investigative Site	Panorama City	California
United States	Investigative Site	Philadelphia	Pennsylvania
United States	Investigative Site	Plantation	Florida
United States	Investigative Sitee	Port Orange	Florida
United States	Investigative Site	Port Saint Lucie	Florida
United States	Investigative Site	Raleigh	North Carolina
United States	Investigative Site	Richmond	Virginia
United States	Investigative Site	San Diego	California
United States	Investigative Site	San Marcos	California
United States	Investigative Site	Shreveport	Louisiana
United States	Investigative Site	Snellville	Georgia
United States	Investigative Site	Spartanburg	South Carolina
United States	Investigative Site	Stockbridge	Georgia
United States	Investigative Site	Sugar Land	Texas
United States	Investigative Site	Tampa	Florida
United States	Investigative Site	Tampa	Florida
United States	Investigative Site	Taylorsville	Utah
United States	Investigative Site	Upland	California
United States	Investigative Site	West Jordan	Utah
United States	Investigative Site	West Palm Beach	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Sucampo Pharma Americas, LLC	Sucampo AG, Sucampo Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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)