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Completed

NCT Number: NCT03097861

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

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).

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Key information

Conditions

Chronic Idiopathic Constipation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigative Site, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lubiprostone

Drug

24 mcg administered orally BID

Other names: Amitiza

Placebo

Drug

24 mcg administered orally BID

Primary outcomes

  1. Observed Spontaneous Bowel Movement (SBM) Count Within 1 Week

    Time frame: during the 1-week treatment period

    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 outcomes

  1. Mean SBM Consistency Score Within 1 Week

    Time frame: during the 1-week treatment period

    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.

  2. Mean SBM Straining Score Within 1 Week

    Time frame: during the 1-week treatment period

    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.

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: From first dose of study medication to follow-up (up to 15 days)

    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.

Sponsors and collaborators

Lead sponsor

Sucampo Pharma Americas, LLC

Industry

Collaborators

  • Sucampo AG
  • Sucampo Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2017
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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