Investigation of KLYX in Patients With Constipation

NCT ID: NCT01335386

Last Updated: 2012-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2010-07-31

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.

Conditions

Constipation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

KLYX

Group Type: EXPERIMENTAL

KLYX

Intervention Type: DRUG

Glycerine

Group Type: ACTIVE_COMPARATOR

Glycerine

Intervention Type: DRUG

Interventions

KLYX

Intervention Type: DRUG

Glycerine

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ferring Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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

Countries

China

Other Identifiers

FECN2006KLY-01

Identifier Type: -

Identifier Source: org_study_id