Investigation of KLYX in Patients With Constipation

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of KLYX Versus Glycerine Enema in Chinese Patients With Constipation - a Randomised, Assessor-blind Pilot Study

Conditions
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Constipation

Intervention / Treatment
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* Drug: KLYX
* Drug: Glycerine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KLYX<br> | Drug: KLYX<br> <br> |
| Active Comparator: Glycerine<br> | Drug: Glycerine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall efficacy of enema |  | immediately following enema administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first bowel movement |  | Immediately following enema administration | 
| Patient's overall satisfaction with enema treatment |  | Immediately following enema administration | 
| Stool form after enema treatment |  | Immediately following enema administration |