Clinical trial NCT01474499: A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Constipation
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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.

Primary outcomes:
measure: Overall efficacy rate of the enema in treating the symptoms of constipation
timeFrame: Up to 30 minutes
Secondary outcomes:
measure: Time from conclusion of enema administration to patient's first bowel movement
timeFrame: Up to 30 minutes
measure: Amount of straining that occurs during bowel movement (normal/difficult)
timeFrame: Up to 30 minutes
measure: Feeling of emptying of the rectum post bowel movement (complete/incomplete)
timeFrame: Up to 30 minutes
measure: Stool form after enema treatment according to Bristol Stool Scale
timeFrame: Up to 30 minutes
measure: Anal complaints (absent, anal itch, anal irritation or anal pain)
timeFrame: Up to 30 minutes
measure: Abdominal pain (absent, mild, moderate, or severe)
timeFrame: Up to 30 minutes
measure: Patient's overall assessment of using the enema to treat the symptoms of constipation
timeFrame: Up to 30 minutes
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Southern Medical University - Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The Second Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiaotong University Medical School - Renji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Jiaotong University Medical School - Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References: