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Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation

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ClinicalTrials.gov Identifier: NCT01993875
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : December 13, 2019
Last Update Posted : December 13, 2019
Sponsor:
Collaborators:
Sucampo Pharma Americas, LLC
Takeda
Sucampo AG
Information provided by (Responsible Party):
Mallinckrodt

Brief Summary:
To evaluate the pharmacodynamics and tolerability of a liquid formulation of lubiprostone, as compared to matching placebo, when administered orally to subjects with chronic idiopathic constipation. Additionally, liquid formulation pharmacokinetics, including a comparison of fed and fasted pharmacokinetics, of the liquid formulation will be performed in a subset of subjects.

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: Lubiprostone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Double-blinded, Multicenter Study of the Pharmacodynamics, Pharmacokinetics, and Tolerability of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Study Start Date : October 2013
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: Lubiprostone Drug: Lubiprostone
Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)

Placebo Comparator: Placebo Drug: Placebo
Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)




Primary Outcome Measures :
  1. Number of Spontaneous Bowel Movements (SBMs) Within 1 Week [ Time Frame: within 1 week ]
    SBM is defined as any bowel movement (BM) that did not occur within the 24-hour period following use of a rescue medication.


Secondary Outcome Measures :
  1. Consistency of SBMs at Week 1 [ Time Frame: at Week 1 ]
    Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.

  2. Overall Stool Consistency at Week 1 [ Time Frame: at Week 1 ]
    Overall stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid.

  3. Mean Change From Baseline in Stool Consistency at Week 1 [ Time Frame: Baseline and Week 1 ]
    Stool consistency was rated according to the 7-point Bristol Stool Form Scale: Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. The change from baseline was calculated as post-treatment value (mean) minus the baseline value (mean).

  4. Overall Straining at Week 1 [ Time Frame: Week 1 ]
    Bowel straining was rated on a scale of 0 to 4 (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe).

  5. Mean Change From Baseline in Straining at Week 1 [ Time Frame: Week 1 ]
    Bowel straining was rated as 0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. The change from baseline was calculated as post-treatment value minus the baseline value.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Medically-confirmed diagnosis of chronic idiopathic constipation
  • Willing to discontinue use of prescribed or over-the-counter (OTC) medication that affects gastrointestinal motility during the study
  • Stable dose of selective serotonin re-uptake inhibitors (SSRIs), serotonin-specific reuptake inhibitor (SNRIs), or monoamine oxidase inhibitors (MAO) inhibitors

Exclusion Criteria:

  • Any gastrointestinal (GI) condition, other than constipation, affecting GI motility or defecation.
  • Medical/surgical condition that might interfere with the absorption, distribution, metabolism, or excretion of the study medication.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01993875


Locations
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United States, Alabama
Anniston, Alabama, United States, 36207
United States, California
Anaheim, California, United States, 92801
United States, Florida
DeLand, Florida, United States, 32720
Hollywood, Florida, United States, 33024
Orlando, Florida, United States, 32809
South Miami, Florida, United States, 33143
United States, Kansas
Overland Park, Kansas, United States, 66212
United States, New Jersey
Marlton, New Jersey, United States, 08053
United States, North Carolina
Raleigh, North Carolina, United States, 27612
United States, Utah
Salt Lake City, Utah, United States, 84106
United States, Wisconsin
West Bend, Wisconsin, United States, 53095
Sponsors and Collaborators
Mallinckrodt
Sucampo Pharma Americas, LLC
Takeda
Sucampo AG
Investigators
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Study Director: Global Clinical Leader Mallinckrodt
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01993875    
Other Study ID Numbers: SCMP-0211-301
First Posted: November 25, 2013    Key Record Dates
Results First Posted: December 13, 2019
Last Update Posted: December 13, 2019
Last Verified: July 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action