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

Study Overview
=================
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.

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

Conditions
-----------------
Constipation

Intervention / Treatment
-----------------
* Drug: Glycerine
* Drug: Docusate sodium and sorbitol rectal solution


Participation Criteria
=================
Eligibility 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: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docusate sodium and sorbitol rectal solution<br> | Drug: Docusate sodium and sorbitol rectal solution<br> <br> |
| Active Comparator: Glycerine<br> | Drug: Glycerine<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall efficacy rate of the enema in treating the symptoms of constipation |  | Up to 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |