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About
The purpose of this study was to evaluate the efficacy and safety of oral administration of lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic constipation (CIC) compared with placebo.
Full description
The drug being tested in this study is called lubiprostone. Lubiprostone is being tested to treat people who have chronic idiopathic constipation. This study will look at the frequency of spontaneous bowel movements (SBMs) in people who take lubiprostone compared to placebo.
The study will enroll 150 participants. Participants will be randomly assigned (by chance, like flipping a coin) equally to one of the two treatment groups, which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):
All participants will be asked to take one capsule with breakfast and one capsule with dinner each day throughout the study. All participants will be asked to record each time they have a SBM and all details of each SBM (including the consistency of the stool and the difficulty they have in passing it) in a diary.
This multi-center trial will be conducted in South Korea. The overall time to participate in this study is 8 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
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Inclusion criteria
In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Has a history of constipation defined as having sudden bowel movement (SBM) frequency of less than 3 times per week on average for 6 months or longer and for whom the SBM frequency is confirmed to meet inclusion criteria observed during the Screening Period.
Has had 1 or more of the symptoms associated with SBM (described below) for 6 months or longer at the start of Screening:
Rarely has loose stools without the use of laxatives.
Is willing and able to keep a diary on his/her own and willing and able to complete a questionnaire.
Is male or female and aged 19 years or older, at the time of signing an informed consent.
A female participant of childbearing potential who is sexually active agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study and 14 days after the last dose of study drug.
Exclusion criteria
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Interventional model
Masking
156 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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