Investigation of KLYX in Patients With Constipation

Phase 2

Completed

• Conditions: Constipation
• Interventions: Drug: KLYX; Drug: Glycerine

• Registration Number: NCT01335386
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-03
• Last Update Posted: 2012-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KLYX	KLYX	-
Glycerine	Glycerine	-

Primary Outcome Measures

Name	Time	Method
Overall efficacy of enema	immediately following enema administration

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Changhai Hospital, The Second Military Medical University; 🇨🇳 Shanghai, China

Ruijin Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China

Renji Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China