Investigation of KLYX in Patients With Constipation

Constipation Clinical Trial

Official title:

Efficacy and Safety of KLYX Versus Glycerine Enema in Chinese Patients With Constipation - a Randomised, Assessor-blind Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335386
• Other study ID #: FECN2006KLY-01
• Status: Completed
• Phase: Phase 2
• First received: April 13, 2011
• Last updated: February 3, 2012
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: February 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• KLYX

• Glycerine

Locations

Country	Name	City	State
China	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

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall efficacy of enema		immediately following enema administration	No
Secondary	Time to first bowel movement		Immediately following enema administration	No
Secondary	Patient's overall satisfaction with enema treatment		Immediately following enema administration	No
Secondary	Stool form after enema treatment		Immediately following enema administration	No