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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01474499
First received: November 16, 2011
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Constipation
Drug: Glycerine
Drug: Docusate sodium and sorbitol rectal solution
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:
  • Overall efficacy rate of the enema in treating the symptoms of constipation [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from conclusion of enema administration to patient's first bowel movement [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ]
  • Amount of straining that occurs during bowel movement (normal/difficult) [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ]
  • Feeling of emptying of the rectum post bowel movement (complete/incomplete) [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ]
  • Stool form after enema treatment according to Bristol Stool Scale [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ]
  • Anal complaints (absent, anal itch, anal irritation or anal pain) [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: Yes ]
  • Abdominal pain (absent, mild, moderate, or severe) [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: Yes ]
  • Patient's overall assessment of using the enema to treat the symptoms of constipation [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: September 2011
Study Completion Date: May 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docusate sodium and sorbitol rectal solution Drug: Docusate sodium and sorbitol rectal solution
Active Comparator: Glycerine Drug: Glycerine

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474499

Locations
China, Guangdong
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
China, Hubei
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China
China, Jiangsu
Nanjing First Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
China, Shanghai
Shanghai Jiaotong University Medical School - Ruijin Hospital
Shanghai, Shanghai, China
Shanghai Jiaotong University Medical School - Renji Hospital
Shanghai, Shanghai, China
Shanghai Changhai Hospital
Shanghai, Shanghai, China
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Study Director: Clinical Development Support Ferring Pharmaceuticals
  More Information

No publications provided

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01474499     History of Changes
Other Study ID Numbers: FE999306 CS01
Study First Received: November 16, 2011
Last Updated: September 24, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms
Pharmaceutical Solutions
Glycerol
Bismuth subsalicylate
Sorbitol
Therapeutic Uses
Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Antidiarrheals
Gastrointestinal Agents
Cathartics

ClinicalTrials.gov processed this record on September 22, 2014