Evaluation of the Bioequivalence of Sprinkle and Capsule Formulations of Lubiprostone, as Compared to Placebo
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
1 other identifier
interventional
552
1 country
67
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2017
Shorter than P25 for phase_3
67 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2017
CompletedFirst Submitted
Initial submission to the registry
March 27, 2017
CompletedFirst Posted
Study publicly available on registry
March 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 17, 2017
CompletedResults Posted
Study results publicly available
January 14, 2020
CompletedJanuary 14, 2020
January 1, 2020
5 months
March 27, 2017
December 13, 2019
January 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Mean SBM Consistency Score Within 1 Week
during the 1-week treatment period
Mean SBM Straining Score Within 1 Week
during the 1-week treatment period
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
From first dose of study medication to follow-up (up to 15 days)
Study Arms (3)
Lubiprostone Capsule
ACTIVE COMPARATORLubiprostone 24 mcg capsule twice daily (BID) for 7 days.
Lubiprostone Sprinkle
EXPERIMENTALLubiprostone 24 mcg sprinkle BID for 7 days.
Placebo
PLACEBO COMPARATORPlacebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.
Interventions
24 mcg administered orally BID
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sucampo Pharma Americas, LLClead
- Sucampo AGcollaborator
- Sucampo Pharmaceuticals, Inc.collaborator
Study Sites (67)
Investigative Site
Birmingham, Alabama, 35216, United States
Investigative Site
Foley, Alabama, 36535, United States
Investigative Site
Little Rock, Arkansas, 72212, United States
Investigative Site
Anaheim, California, 92805, United States
Investigative Sitee
Chula Vista, California, 91910, United States
Investigative Site
Garden Grove, California, 92840, United States
Investigative Site
Long Beach, California, 90806, United States
Investigative Site
Los Angeles, California, 90057, United States
Investigative Site
Panorama City, California, 91402, United States
Investigative Site
San Diego, California, 92103, United States
Investigative Site
San Marcos, California, 92078, United States
Investigative Site
Upland, California, 91786, United States
Investigative Site
Colorado Springs, Colorado, 80909, United States
Investigative Site
New London, Connecticut, 06320, United States
Investigative Site
Clearwater, Florida, 33765, United States
Investigative Site
Coral Springs, Florida, 33065, United States
Investigative Site
DeLand, Florida, 32720, United States
Investigative Site
Hialeah, Florida, 33012, United States
Investigative Site
Jupiter, Florida, 33458, United States
Investigative Site
Miami, Florida, 33142, United States
Investigative Site 2
Miami, Florida, 33143, United States
Investigative Site
Miami, Florida, 33143, United States
Investigative Site
Miami, Florida, 33165, United States
Investigative Site
Orlando, Florida, 32806, United States
Investigative Site
Plantation, Florida, 33322, United States
Investigative Sitee
Port Orange, Florida, 32129, United States
Investigative Site
Port Saint Lucie, Florida, 34952, United States
Investigative Site
Tampa, Florida, 33609, United States
Investigative Site
Tampa, Florida, 33634, United States
Investigative Site
West Palm Beach, Florida, 33409, United States
Investigative Site
Athens, Georgia, 30607, United States
Investigative Site
Snellville, Georgia, 30078, United States
Investigative Site
Stockbridge, Georgia, 30281, United States
Investigative Site
Blackfoot, Idaho, 83221, United States
Investigative Site
Boise, Idaho, 83712, United States
Investigative Site
Meridian, Idaho, 83642, United States
Investigative Site
Lake Charles, Louisiana, 70601, United States
Investigative Site
New Orleans, Louisiana, 70124, United States
Investigative Site
Shreveport, Louisiana, 71101, United States
Investigative Site
Chevy Chase, Maryland, 20815, United States
Investigative Site
Hagerstown, Maryland, 21742, United States
Investigative Site
New Bedford, Massachusetts, 02740, United States
Investigative Site
Jackson, Missouri, 39202, United States
Investigative Sitee
Bellevue, Nebraska, 68005, United States
Investigative Site
Las Vegas, Nevada, 89119, United States
Investigative Site
The Bronx, New York, 10459, United States
Investigative Sitee
High Point, North Carolina, 27262, United States
Investigative Site
Raleigh, North Carolina, 27612, United States
Investigative Site
Cleveland, Ohio, 44122, United States
Investigative Site
Mentor, Ohio, 44060, United States
Investigative Site
Midwest City, Oklahoma, 73110, United States
Investigative Site
Philadelphia, Pennsylvania, 19152, United States
Investigative Site
Charleston, South Carolina, 29406, United States
Investigative Site
Spartanburg, South Carolina, 29303, United States
Investigative Site
Chattanooga, Tennessee, 37421, United States
Investigative Site 2
Jackson, Tennessee, 38305, United States
Investigative Site
Jackson, Tennessee, 38305, United States
Investigative Site
Houston, Texas, 77058, United States
Investigative Site
Houston, Texas, 77099, United States
Investigative Site
Longview, Texas, 75605, United States
Investigative Site
McAllen, Texas, 78504, United States
Investigative Site
Sugar Land, Texas, 77479, United States
Investigative Site
Layton, Utah, 84041, United States
Investigative Site
Taylorsville, Utah, 84123, United States
Investigative Site
West Jordan, Utah, 84088, United States
Investigative Site
Newport News, Virginia, 23606, United States
Investigative Site
Richmond, Virginia, 23220, United States
Related Publications (1)
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.
PMID: 33834354DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Actual randomization ratio (2:1:1) was different than the planned ratio (1:1:1).
Results Point of Contact
- Title
- Medical Information Call Center
- Organization
- Mallinckrodt Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Global Clinical Leader
Mallinckrodt
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2017
First Posted
March 31, 2017
Study Start
March 13, 2017
Primary Completion
August 17, 2017
Study Completion
August 17, 2017
Last Updated
January 14, 2020
Results First Posted
January 14, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share