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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

November 16, 2011
September 24, 2012
September 2011
March 2012   (final data collection date for primary outcome measure)
Overall efficacy rate of the enema in treating the symptoms of constipation [ Time Frame: Up to 30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01474499 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Constipation
  • Drug: Glycerine
  • Drug: Docusate sodium and sorbitol rectal solution
  • Experimental: Docusate sodium and sorbitol rectal solution
    Intervention: Drug: Docusate sodium and sorbitol rectal solution
  • Active Comparator: Glycerine
    Intervention: Drug: Glycerine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01474499
FE999306 CS01
No
Ferring Pharmaceuticals
Ferring Pharmaceuticals
Not Provided
Study Director: Clinical Development Support Ferring Pharmaceuticals
Ferring Pharmaceuticals
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP