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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03097861
Other study ID # SCMP-0211-302
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
See also
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