Investigation of KLYX in Patients With Constipation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01335386
First received: April 13, 2011
Last updated: February 3, 2012
Last verified: February 2012
  Purpose

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 Intervention Phase
Constipation
Drug: KLYX
Drug: Glycerine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Overall efficacy of enema [ Time Frame: immediately following enema administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first bowel movement [ Time Frame: Immediately following enema administration ] [ Designated as safety issue: No ]
  • Patient's overall satisfaction with enema treatment [ Time Frame: Immediately following enema administration ] [ Designated as safety issue: No ]
  • Stool form after enema treatment [ Time Frame: Immediately following enema administration ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: April 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KLYX Drug: KLYX
Active Comparator: Glycerine Drug: Glycerine

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01335386

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

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01335386     History of Changes
Other Study ID Numbers: FECN2006KLY-01
Study First Received: April 13, 2011
Last Updated: February 3, 2012
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 26, 2014