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

Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01474499
• Other study ID #: FE999306 CS01
• Status: Completed
• Phase: Phase 3
• First received: November 16, 2011
• Last updated: September 24, 2012
• Start date: September 2011
• Est. completion date: May 2012

Study information

• Verified date: September 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Drug:
• Glycerine

• Docusate sodium and sorbitol rectal solution

Locations

Country	Name	City	State
China	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	Nanjing First Hospital	Nanjing	Jiangsu
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu
China	Shanghai Changhai Hospital	Shanghai	Shanghai
China	Shanghai Jiaotong University Medical School - Renji Hospital	Shanghai	Shanghai
China	Shanghai Jiaotong University Medical School - Ruijin Hospital	Shanghai	Shanghai
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall efficacy rate of the enema in treating the symptoms of constipation		Up to 30 minutes	No
Secondary	Time from conclusion of enema administration to patient's first bowel movement		Up to 30 minutes	No
Secondary	Amount of straining that occurs during bowel movement (normal/difficult)		Up to 30 minutes	No
Secondary	Feeling of emptying of the rectum post bowel movement (complete/incomplete)		Up to 30 minutes	No
Secondary	Stool form after enema treatment according to Bristol Stool Scale		Up to 30 minutes	No
Secondary	Anal complaints (absent, anal itch, anal irritation or anal pain)		Up to 30 minutes	Yes
Secondary	Abdominal pain (absent, mild, moderate, or severe)		Up to 30 minutes	Yes
Secondary	Patient's overall assessment of using the enema to treat the symptoms of constipation		Up to 30 minutes	No