Investigation of KLYX in Patients With Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01335386
Recruitment Status : Completed
First Posted : April 14, 2011
Last Update Posted : February 6, 2012
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Constipation Drug: KLYX Drug: Glycerine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Efficacy and Safety of KLYX Versus Glycerine Enema in Chinese Patients With Constipation - a Randomised, Assessor-blind Pilot Study
Study Start Date : April 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Glycerin

Arm Intervention/treatment
Experimental: KLYX Drug: KLYX
Active Comparator: Glycerine Drug: Glycerine

Primary Outcome Measures :
  1. Overall efficacy of enema [ Time Frame: immediately following enema administration ]

Secondary Outcome Measures :
  1. Time to first bowel movement [ Time Frame: Immediately following enema administration ]
  2. Patient's overall satisfaction with enema treatment [ Time Frame: Immediately following enema administration ]
  3. Stool form after enema treatment [ Time Frame: Immediately following enema administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01335386

Changhai Hospital, The Second Military Medical University
Shanghai, China
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Ferring Pharmaceuticals
Study Director: Clinical Development Support Ferring Pharmaceuticals

Responsible Party: Ferring Pharmaceuticals Identifier: NCT01335386     History of Changes
Other Study ID Numbers: FECN2006KLY-01
First Posted: April 14, 2011    Key Record Dates
Last Update Posted: February 6, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs