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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

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE October 14, 2019
Results First Posted Date  ICMJE December 13, 2019
Last Update Posted Date December 13, 2019
Study Start Date  ICMJE October 2013
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
Spontaneous Bowel Movement frequency rate [ Time Frame: Week 1 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 26, 2019)
  • 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.
  • 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.
  • 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).
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2013)
  • Change from baseline in Spontaneous Bowel Movement frequency rate [ Time Frame: Week 1 ]
  • Overall and mean change from baseline in stool consistency [ Time Frame: Week 1 ]
  • Overall and mean change from baseline in straining [ Time Frame: Week 1 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacodynamic, Pharmacokinetic, and Tolerability Study of a Liquid Form of Lubiprostone in Adult Subjects With Chronic Idiopathic Constipation
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Idiopathic Constipation
Intervention  ICMJE
  • Drug: Lubiprostone
    Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)
  • Drug: Placebo
    Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
Study Arms  ICMJE
  • Experimental: Lubiprostone
    Intervention: Drug: Lubiprostone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 24, 2014)
164
Original Estimated Enrollment  ICMJE
 (submitted: November 22, 2013)
152
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01993875
Other Study ID Numbers  ICMJE SCMP-0211-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mallinckrodt
Study Sponsor  ICMJE Mallinckrodt
Collaborators  ICMJE
  • Sucampo Pharma Americas, LLC
  • Takeda
  • Sucampo AG
Investigators  ICMJE
Study Director: Global Clinical Leader Mallinckrodt
PRS Account Mallinckrodt
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP