Investigation of KLYX in Patients With Constipation

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomised, assessor-blind, multi-centre pilot study to investigate the comparative safety and efficacy of KLYX and glycerine enema in the symptomatic treatment of constipation in Chinese patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Glycerol

Criteria

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