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

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.