Investigation of KLYX in Patients With Constipation

Inclusion criteria

• Have signed the informed consent form and have been verbally explained the details of the trial and treatment procedures
• Ethnically Chinese
• Males or females aged between 18 and 65 years inclusive
• A history of constipation symptoms for at least 6 months fulfilling, with occurrence of two or more of the following symptoms during the 3 months before screening (the 3 months need not be consecutive):

i. Very hard (pellet-like) and/or hard stools (Type 1 or 2 of the Bristol Stool Scale) for at least 25% of the time; or ii. Sensation of incomplete evacuation at least 25% of the time; or iii. Straining during defecation at least 25% of the time; or iv. Sensation of anorectal obstruction or blockage often during defecation at least 25% of the time; or v. Manual manoeuvres needed often to facilitate defecations (e.g. digital evacuation, support of the pelvic floor) at least 25% of the time; or vi. Fewer than 3 defecations per week.

• Patient has had no bowel movement (i.e. still constipated) two days prior randomisation.

Exclusion criteria

• Any disorder or laboratory result at Screening that in the judgement of the investigator that will place the subject at excessive risk if participating in a controlled study
• Clinically suspected to have colorectal cancer
• Significant gastroparesis or gastric outlet obstruction
• Hypersensitivity to sodium docusate and/or sorbitol
• Hypersensitivity to glycerine
• Pregnant or lactating women, women who intend to conceive, or women who are sexually active and capable of pregnancy who are not using a method of birth control (e.g. prescription hormonal contraceptives, intrauterine device, double-barrier method, male partner sterilization)
• Diabetic patients currently on insulin therapy
• Having participated in other clinical trial(s) within the 3 (three) months prior screening
• Unable to withdraw medications that may affect gastrointestinal motility such as prokinetics, erythromycin analogues, laxatives, etc.
• Unable to meet or perform study requirements: known or suspected inability to comply with the study protocol