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

Primary Purpose

Chronic Idiopathic Constipation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lubiprostone
Placebo
Sponsored by
Sucampo Pharma Americas, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Idiopathic Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Placebo Comparator

Arm Label

Lubiprostone Capsule

Lubiprostone Sprinkle

Placebo

Arm Description

Lubiprostone 24 mcg capsule twice daily (BID) for 7 days.

Lubiprostone 24 mcg sprinkle BID for 7 days.

Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 27, 2017
Last Updated
January 10, 2020
Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo AG, Sucampo Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03097861
Brief Title
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 13, 2017 (Actual)
Primary Completion Date
August 17, 2017 (Actual)
Study Completion Date
August 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sucampo Pharma Americas, LLC
Collaborators
Sucampo AG, Sucampo Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Idiopathic Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
552 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubiprostone Capsule
Arm Type
Active Comparator
Arm Description
Lubiprostone 24 mcg capsule twice daily (BID) for 7 days.
Arm Title
Lubiprostone Sprinkle
Arm Type
Experimental
Arm Description
Lubiprostone 24 mcg sprinkle BID for 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo matching to lubiprostone (sprinkle/capsule) BID for 7 days.
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza
Intervention Description
24 mcg administered orally BID
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
24 mcg administered orally BID
Primary Outcome Measure Information:
Title
Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week
Description
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.
Time Frame
during the 1-week treatment period
Secondary Outcome Measure Information:
Title
Mean SBM Consistency Score Within 1 Week
Description
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.
Time Frame
during the 1-week treatment period
Title
Mean SBM Straining Score Within 1 Week
Description
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.
Time Frame
during the 1-week treatment period
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
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.
Time Frame
From first dose of study medication to follow-up (up to 15 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Investigative Site
City
Foley
State/Province
Alabama
ZIP/Postal Code
36535
Country
United States
Facility Name
Investigative Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Investigative Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Investigative Sitee
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Investigative Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Investigative Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
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United States
Facility Name
Investigative Site
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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United States
Facility Name
Investigative Site
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San Marcos
State/Province
California
ZIP/Postal Code
92078
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United States
Facility Name
Investigative Site
City
Upland
State/Province
California
ZIP/Postal Code
91786
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United States
Facility Name
Investigative Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
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United States
Facility Name
Investigative Site
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
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United States
Facility Name
Investigative Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
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United States
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Investigative Site
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Coral Springs
State/Province
Florida
ZIP/Postal Code
33065
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United States
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Investigative Site
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DeLand
State/Province
Florida
ZIP/Postal Code
32720
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United States
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Investigative Site
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Hialeah
State/Province
Florida
ZIP/Postal Code
33012
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United States
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Investigative Site
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Jupiter
State/Province
Florida
ZIP/Postal Code
33458
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United States
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Investigative Site
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Miami
State/Province
Florida
ZIP/Postal Code
33142
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United States
Facility Name
Investigative Site 2
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
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United States
Facility Name
Investigative Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
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United States
Facility Name
Investigative Site
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Miami
State/Province
Florida
ZIP/Postal Code
33165
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United States
Facility Name
Investigative Site
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Orlando
State/Province
Florida
ZIP/Postal Code
32806
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United States
Facility Name
Investigative Site
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Plantation
State/Province
Florida
ZIP/Postal Code
33322
Country
United States
Facility Name
Investigative Sitee
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
Country
United States
Facility Name
Investigative Site
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Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
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United States
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Investigative Site
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Tampa
State/Province
Florida
ZIP/Postal Code
33609
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United States
Facility Name
Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
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United States
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Investigative Site
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West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
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United States
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Investigative Site
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Athens
State/Province
Georgia
ZIP/Postal Code
30607
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United States
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Investigative Site
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Snellville
State/Province
Georgia
ZIP/Postal Code
30078
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United States
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Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
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United States
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Blackfoot
State/Province
Idaho
ZIP/Postal Code
83221
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United States
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Boise
State/Province
Idaho
ZIP/Postal Code
83712
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United States
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Investigative Site
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Meridian
State/Province
Idaho
ZIP/Postal Code
83642
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United States
Facility Name
Investigative Site
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Lake Charles
State/Province
Louisiana
ZIP/Postal Code
70601
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United States
Facility Name
Investigative Site
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New Orleans
State/Province
Louisiana
ZIP/Postal Code
70124
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United States
Facility Name
Investigative Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
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United States
Facility Name
Investigative Site
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Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
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United States
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Investigative Site
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Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
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United States
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Investigative Site
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New Bedford
State/Province
Massachusetts
ZIP/Postal Code
02740
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United States
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Investigative Site
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Jackson
State/Province
Missouri
ZIP/Postal Code
39202
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United States
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Investigative Sitee
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Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
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United States
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Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
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United States
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Bronx
State/Province
New York
ZIP/Postal Code
10459
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United States
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Investigative Sitee
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
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United States
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Investigative Site
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Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
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United States
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Investigative Site
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Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
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United States
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Investigative Site
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Mentor
State/Province
Ohio
ZIP/Postal Code
44060
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United States
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Midwest City
State/Province
Oklahoma
ZIP/Postal Code
73110
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United States
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Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
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United States
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Investigative Site
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Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
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United States
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Investigative Site
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Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
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United States
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Investigative Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Investigative Site 2
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Investigative Site
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77058
Country
United States
Facility Name
Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Investigative Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Investigative Site
City
McAllen
State/Province
Texas
ZIP/Postal Code
78504
Country
United States
Facility Name
Investigative Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Investigative Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
Investigative Site
City
Taylorsville
State/Province
Utah
ZIP/Postal Code
84123
Country
United States
Facility Name
Investigative Site
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Investigative Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23220
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33834354
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. Erratum In: Adv Ther. 2021 May 24;:
Results Reference
derived

Learn more about this trial

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

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