Clinical trial NCT01335386: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Overall efficacy of enema
timeFrame: immediately following enema administration
Secondary outcomes:
measure: Time to first bowel movement
timeFrame: Immediately following enema administration
measure: Patient's overall satisfaction with enema treatment
timeFrame: Immediately following enema administration
measure: Stool form after enema treatment
timeFrame: Immediately following enema administration
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, The Second Military Medical University
city: Shanghai
country: China
facility: Renji Hospital, Shanghai Jiaotong University School of Medicine
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: