Investigation of KLYX in Patients With Constipation

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

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: KLYX; Drug: Glycerine

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • Renji Hospital, Shanghai Jiaotong University School of Medicine
  • Shanghai, China
    • ChangHai Hospital, The Second Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KLYX	Drug: KLYX
Active Comparator: Glycerine	Drug: Glycerine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall efficacy of enema	immediately following enema administration

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): July 1, 2010

Study Registration Dates

• First Submitted: April 13, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Estimate): February 6, 2012
• Last Update Submitted That Met QC Criteria: February 3, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Physiological Effects of Drugs; Protective Agents; Cryoprotective Agents; Glycerol
• Other Study ID Numbers: FECN2006KLY-01