Clinical trial NCT03097861: Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Idiopathic Constipation
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
Collaborators: name: Sucampo AG
name: Sucampo Pharmaceuticals, Inc.
First posted: 2017-03-31
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
timeFrame: during the 1-week treatment period
Secondary outcomes:
measure: Mean SBM Consistency Score Within 1 Week
timeFrame: during the 1-week treatment period
measure: Mean SBM Straining Score Within 1 Week
timeFrame: during the 1-week treatment period
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From first dose of study medication to follow-up (up to 15 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigative Site
state: Alabama
city: Foley
country: United States
facility: Investigative Site
state: Alabama
city: Little Rock
country: United States
facility: Investigative Site
state: Arkansas
city: Anaheim
country: United States
facility: Investigative Site
state: California
city: Chula Vista
country: United States
facility: Investigative Sitee
state: California
city: Garden Grove
country: United States
facility: Investigative Site
state: California
city: Long Beach
country: United States
facility: Investigative Site
state: California
city: Los Angeles
country: United States
facility: Investigative Site
state: California
city: Panorama City
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: San Marcos
country: United States
facility: Investigative Site
state: California
city: Upland
country: United States
facility: Investigative Site
state: California
city: Colorado Springs
country: United States
facility: Investigative Site
state: Colorado
city: New London
country: United States
facility: Investigative Site
state: Connecticut
city: Clearwater
country: United States
facility: Investigative Site
state: Florida
city: Coral Springs
country: United States
facility: Investigative Site
state: Florida
city: DeLand
country: United States
facility: Investigative Site
state: Florida
city: Hialeah
country: United States
facility: Investigative Site
state: Florida
city: Jupiter
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site 2
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Orlando
country: United States
facility: Investigative Site
state: Florida
city: Plantation
country: United States
facility: Investigative Site
state: Florida
city: Port Orange
country: United States
facility: Investigative Sitee
state: Florida
city: Port Saint Lucie
country: United States
facility: Investigative Site
state: Florida
city: Tampa
country: United States
facility: Investigative Site
state: Florida
city: Tampa
country: United States
facility: Investigative Site
state: Florida
city: West Palm Beach
country: United States
facility: Investigative Site
state: Florida
city: Athens
country: United States
facility: Investigative Site
state: Georgia
city: Snellville
country: United States
facility: Investigative Site
state: Georgia
city: Stockbridge
country: United States
facility: Investigative Site
state: Georgia
city: Blackfoot
country: United States
facility: Investigative Site
state: Idaho
city: Boise
country: United States
facility: Investigative Site
state: Idaho
city: Meridian
country: United States
facility: Investigative Site
state: Idaho
city: Lake Charles
country: United States
facility: Investigative Site
state: Louisiana
city: New Orleans
country: United States
facility: Investigative Site
state: Louisiana
city: Shreveport
country: United States
facility: Investigative Site
state: Louisiana
city: Chevy Chase
country: United States
facility: Investigative Site
state: Maryland
city: Hagerstown
country: United States
facility: Investigative Site
state: Maryland
city: New Bedford
country: United States
facility: Investigative Site
state: Massachusetts
city: Jackson
country: United States
facility: Investigative Site
state: Missouri
city: Bellevue
country: United States
facility: Investigative Sitee
state: Nebraska
city: Las Vegas
country: United States
facility: Investigative Site
state: Nevada
city: Bronx
country: United States
facility: Investigative Site
state: New York
city: High Point
country: United States
facility: Investigative Sitee
state: North Carolina
city: Raleigh
country: United States
facility: Investigative Site
state: North Carolina
city: Cleveland
country: United States
facility: Investigative Site
state: Ohio
city: Mentor
country: United States
facility: Investigative Site
state: Ohio
city: Midwest City
country: United States
facility: Investigative Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Investigative Site
state: Pennsylvania
city: Charleston
country: United States
facility: Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Investigative Site
state: South Carolina
city: Chattanooga
country: United States
facility: Investigative Site
state: Tennessee
city: Jackson
country: United States
facility: Investigative Site 2
state: Tennessee
city: Jackson
country: United States
facility: Investigative Site
state: Tennessee
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Houston
country: United States
facility: Investigative Site
state: Texas
city: Longview
country: United States
facility: Investigative Site
state: Texas
city: McAllen
country: United States
facility: Investigative Site
state: Texas
city: Sugar Land
country: United States
facility: Investigative Site
state: Texas
city: Layton
country: United States
facility: Investigative Site
state: Utah
city: Taylorsville
country: United States
facility: Investigative Site
state: Utah
city: West Jordan
country: United States
facility: Investigative Site
state: Utah
city: Newport News
country: United States
facility: Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Investigative Site
state: Virginia
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Adams A, Barish C, Chen A, Dennis P, Krause R, Lichtlen P, Losch-Beridon T, Mareya S, Schneider J. Capsule and Sprinkle Formulations of Lubiprostone Are Not Biologically Similar in Patients with Functional Constipation. Adv Ther. 2021 Jun;38(6):2936-2952. doi: 10.1007/s12325-021-01707-9. Epub 2021 Apr 8.