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Investigation of KLYX in Patients With Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
KLYX
Glycerine
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Constipation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

KLYX

Glycerine

Arm Description

Outcomes

Primary Outcome Measures

Overall efficacy of enema

Secondary Outcome Measures

Time to first bowel movement
Patient's overall satisfaction with enema treatment
Stool form after enema treatment

Full Information

First Posted
April 13, 2011
Last Updated
February 3, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01335386
Brief Title
Investigation of KLYX in Patients With Constipation
Official Title
Efficacy and Safety of KLYX Versus Glycerine Enema in Chinese Patients With Constipation - a Randomised, Assessor-blind Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KLYX
Arm Type
Experimental
Arm Title
Glycerine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
KLYX
Intervention Type
Drug
Intervention Name(s)
Glycerine
Primary Outcome Measure Information:
Title
Overall efficacy of enema
Time Frame
immediately following enema administration
Secondary Outcome Measure Information:
Title
Time to first bowel movement
Time Frame
Immediately following enema administration
Title
Patient's overall satisfaction with enema treatment
Time Frame
Immediately following enema administration
Title
Stool form after enema treatment
Time Frame
Immediately following enema administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Changhai Hospital, The Second Military Medical University
City
Shanghai
Country
China
Facility Name
Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
Country
China

12. IPD Sharing Statement

Learn more about this trial

Investigation of KLYX in Patients With Constipation

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