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

A Multi-center, Randomized, Single-blind Clinical Study of the Comparative Safety and Efficacy of Docusate Sodium and Sorbitol Rectal Solution and Glycerine Enemas in Patients With Constipation

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.

Study Overview

• Status: Completed
• Conditions: Constipation
• Intervention / Treatment: Drug: Glycerine; Drug: Docusate sodium and sorbitol rectal solution

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital, Sun Yat-sen University
    • Guangzhou, Guangdong, China
      • Southern Medical University - Nanfang Hospital
    • Guangzhou, Guangdong, China
      • The Second Affiliated Hospital, Sun Yat-Sen University
  • Hubei
    • Wuhan, Hubei, China
      • Zhongnan Hospital of Wuhan University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing First Hospital
    • Nanjing, Jiangsu, China
      • The First Affiliated Hospital with Nanjing Medical University
  • Shanghai
    • Shanghai, Shanghai, China
      • Shanghai Changhai Hospital
    • Shanghai, Shanghai, China
      • Shanghai Jiaotong University Medical School - Renji Hospital
    • Shanghai, Shanghai, China
      • Shanghai Jiaotong University Medical School - Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glycerine	Drug: Glycerine
Experimental: Docusate sodium and sorbitol rectal solution	Drug: Docusate sodium and sorbitol rectal solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall efficacy rate of the enema in treating the symptoms of constipation	Up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Time from conclusion of enema administration to patient's first bowel movement	Up to 30 minutes
Amount of straining that occurs during bowel movement (normal/difficult)	Up to 30 minutes
Feeling of emptying of the rectum post bowel movement (complete/incomplete)	Up to 30 minutes
Stool form after enema treatment according to Bristol Stool Scale	Up to 30 minutes
Anal complaints (absent, anal itch, anal irritation or anal pain)	Up to 30 minutes
Abdominal pain (absent, mild, moderate, or severe)	Up to 30 minutes
Patient's overall assessment of using the enema to treat the symptoms of constipation	Up to 30 minutes

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 16, 2011
• First Posted (Estimate): November 18, 2011

Study Record Updates

• Last Update Posted (Estimate): September 25, 2012
• Last Update Submitted That Met QC Criteria: September 24, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Physiological Effects of Drugs; Gastrointestinal Agents; Protective Agents; Cathartics; Cryoprotective Agents; Antidiarrheals; Sorbitol; Glycerol; Bismuth subsalicylate
• Other Study ID Numbers: FE999306 CS01