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

Sponsor

Ferring Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01474499

Collaborator

(none)

300

Enrollment

Locations

Arms

Duration (Months)

33.3

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation	Drug: Glycerine Drug: Docusate sodium and sorbitol rectal solution	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Docusate sodium and sorbitol rectal solution

Drug: Docusate sodium and sorbitol rectal solution

Active Comparator: Glycerine

Drug: Glycerine

Outcome Measures

Primary Outcome Measures

Overall efficacy rate of the enema in treating the symptoms of constipation [Up to 30 minutes]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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

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

Locations

	Site	City	State	Country
1	Southern Medical University - Nanfang Hospital	Guangzhou	Guangdong	China
2	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
3	The Second Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China
4	Zhongnan Hospital of Wuhan University	Wuhan	Hubei	China
5	Nanjing First Hospital	Nanjing	Jiangsu	China
6	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu	China
7	Shanghai Changhai Hospital	Shanghai	Shanghai	China
8	Shanghai Jiaotong University Medical School - Renji Hospital	Shanghai	Shanghai	China
9	Shanghai Jiaotong University Medical School - Ruijin Hospital	Shanghai	Shanghai	China

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director: Clinical Development Support, Ferring Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ferring Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01474499

Other Study ID Numbers:

FE999306 CS01

First Posted:

Nov 18, 2011

Last Update Posted:

Sep 25, 2012

Last Verified:

Sep 1, 2012

Additional relevant MeSH terms:

Constipation

Sorbitol

Bismuth subsalicylate

Glycerol

Study Results

No Results Posted as of Sep 25, 2012