Investigation of KLYX in Patients With Constipation

Ferring

Status and phase

Completed

Phase 2

Conditions

Constipation

Treatments

Drug: Glycerine

Drug: KLYX

Study type

Interventional

Funder types

Industry

Identifiers

NCT01335386

FECN2006KLY-01

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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