NCT01335386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
Last Updated

February 6, 2012

Status Verified

February 1, 2012

Enrollment Period

3 months

First QC Date

April 13, 2011

Last Update Submit

February 3, 2012

Conditions

Constipation

Outcome Measures

Primary Outcomes (1)

  • Overall efficacy of enema

    immediately following enema administration

Secondary Outcomes (3)

  • 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

Study Arms (2)

KLYX

EXPERIMENTAL
Drug: KLYX

Glycerine

ACTIVE COMPARATOR
Drug: Glycerine

Interventions

KLYXDRUG
KLYX
GlycerineDRUG
Glycerine

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Changhai Hospital, The Second Military Medical University

Shanghai, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Constipation

Interventions

Glycerol

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triose Sugar AlcoholsSugar AlcoholsAlcoholsOrganic ChemicalsCarbohydrates

Study Officials

  • Clinical Development Support

    Ferring Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 14, 2011

Study Start

April 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

February 6, 2012

Record last verified: 2012-02

Locations

CN(3)