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

NCT01474499 | Completed Phase 3

• 1 other identifier: FE999306 CS01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 9

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

Outcome Measures

Primary Outcomes (1)

• Overall efficacy rate of the enema in treating the symptoms of constipation

  Up to 30 minutes

Secondary Outcomes (7)

• 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

Study Arms (2)

Docusate sodium and sorbitol rectal solution

EXPERIMENTAL

Drug: Docusate sodium and sorbitol rectal solution

Glycerine

ACTIVE COMPARATOR

Drug: Glycerine

Interventions

Glycerine DRUG

Glycerine

Docusate sodium and sorbitol rectal solution DRUG

Docusate sodium and sorbitol rectal solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• More than 1/4 of stool classifiable as Type I or Type II on the Bristol Stool Scale;
• Sensation of incomplete evacuation at least 1/4 of the time;
• Straining during defecation at least 1/4 of the time;
• Sensation of ano-rectal blockage or obstruction during defecation at least 1/4 of the time;
• Manual manoeuvres needed often to facilitate defecations (e.g. digital evacuation) at least 1/4 of the time;
• Fewer than 3 bowel movements per week
• No bowel movement within two days prior to randomisation

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (9)

Southern Medical University - Nanfang Hospital

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Second Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Location

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Jiaotong University Medical School - Renji Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai Jiaotong University Medical School - Ruijin Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Constipation

Interventions

Glycerol; Dioctyl Sulfosuccinic Acid

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Succinates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 18, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

CN (9)