Lubiprostone for Treatment of Chronic Idiopathic Constipation

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:
• Scybalum stool or hard feces in at least 1 out of every4 bowel movements.
• Sensation of incomplete evacuation in at least 1 out of every 4 bowel movements.
• Straining in at least 1 out of every 4 bowel movements.
• 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

• Has received any investigational compound within 30 days prior to Screening.
• Has received lubiprostone in a previous clinical study or as a therapeutic agent.
• Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
• Has, in the judgment of the investigator, clinically significant abnormal hematological parameters of hemoglobin, hematocrit, or erythrocytes at Screening.
• Has a history or clinical manifestations of significant mechanical obstruction (intestinal obstruction due to tumor, hernia etc).
• Has a history of hypersensitivity or allergies to lubiprostone or any of its excipients.
• Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening Visit.
• Is required to take excluded medications.
• If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period.
• Participant whose constipation is considered to be due to drugs or to whom a prohibited concomitant medication has been administered.
• Is having chronic constipation due to a secondary cause (medications, diabetes mellitus, hypothyroidism, depression, etc.)
• Has sufficient criteria for irritable bowel syndrome (IBS) or functional defecation disorder.
• Participant whose SBM frequency is 3 or more per week.
• Participant whose SBM frequency has been less than 3 times per week for less than 6 months in duration or whose symptoms associated with SBM have been present for less than 6 months (hard feces, sensation of incomplete evacuation, or straining).
• Has received treatment with a rescue medication within 24 hours prior to the first dose in the morning of Day 1: bisacodyl suppository, which is a standard laxative, glycerin enema, or any other rescue medication.
• Has megacolon/megarectum or has received a diagnosis of intestinal pseudo-obstruction.
• Has confirmed or suspected organic disorders of the large intestine (obstruction, stenosis, carcinoma, or inflammatory bowel disease). Organic disorders of the large intestine can be confirmed or ruled out using the results of enema X-ray examination or total colonoscopy performed in the previous 2 years. If the participant has no history or shows no cu