A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation

NCT ID: NCT01474499

Last Updated: 2012-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-05-31

Brief Summary

This study aims to evaluate the efficacy and safety of the docusate sodium and sorbitol rectal solution produced by Ferring Pharmaceutical (China) Ltd. in treating Chinese patients with constipation.

Conditions

Constipation

Study Design

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

Study Groups

Docusate sodium and sorbitol rectal solution

Group Type: EXPERIMENTAL

Docusate sodium and sorbitol rectal solution

Intervention Type: DRUG

Glycerine

Group Type: ACTIVE_COMPARATOR

Glycerine

Intervention Type: DRUG

Interventions

Glycerine

Intervention Type: DRUG

Docusate sodium and sorbitol rectal solution

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have signed the informed consent form and have been verbally told of the details of the trial and treatment procedures
• Is a citizen of the People's Republic of China
• Males and females aged between 18 and 65 years inclusive
• A history of constipation symptoms for at least 6 months, with occurrence of two or more of the symptoms during the 3 months before screening:

1. More than 1/4 of stool classifiable as Type I or Type II on the Bristol Stool Scale;

2. Sensation of incomplete evacuation at least 1/4 of the time;

3. Straining during defecation at least 1/4 of the time;

4. Sensation of ano-rectal blockage or obstruction during defecation at least 1/4 of the time;

5. Manual manoeuvres needed often to facilitate defecations (e.g. digital evacuation) at least 1/4 of the time;

6. Fewer than 3 bowel movements per week

• No bowel movement within two days prior to randomisation

Exclusion Criteria

• Patients who are suspected to have colorectal cancer;
• Patients showing signs of bleeding in the digestive tract or inflammatory bowel disease;
• Patients experiencing abdominal discomfort or intestinal blockage for which the cause has yet to be determined;
• Patients allergic to docusate or sorbitol;
• Patients allergic to glycerine;
• Those pregnant, breastfeeding, or with the intention of becoming pregnant, or fertile women who are not on effective birth control（i.e. an IUD (intrauterine device), oral contraceptives or other obstructive measures;
• Severe liver damage (ALT (alanine aminotransferase), AST (aspartate transaminase), TBIL (serum total bilirubin) more than 2 times the upper limit of normal)
• Kidney function impairment (Cr (creatinine clearance rate), BUN (blood urea nitrogen) more than 1.5 times the upper limit of normal)
• Patients who have participated in any other clinical trial during the last 3 months;
• Diabetics who are currently undergoing insulin treatment;
• Patients who are unable to suspend using treatments that affect the kinetics of the digestive system in the 5 days prior randomisation. Such treatments include prokinetic drugs, erythromycin analogues, laxatives, etc;
• Other patient factor(s) (e.g. medical history, concurrent illness(es), laboratory test result(s), etc.) at Screening that in the opinion of the investigator(s) would put the trial patient at excessive risk;
• Patients who are unable to act in a legal capacity, unable to meet or perform study requirements, or are known or suspected as unable 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

Southern Medical University - Nanfang Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Second Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Nanjing First Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Shanghai Jiaotong University Medical School - Renji Hospital

Shanghai, Shanghai Municipality, China

Shanghai Jiaotong University Medical School - Ruijin Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

FE999306 CS01

Identifier Type: -

Identifier Source: org_study_id