A Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Lubiprostone Soft Gelatin capsules 24 mcg Vs Bisacodyl tablet 10 mg in the patients with chronic constipation.
- Conditions
- Health Condition 1: null- chronic constipationHealth Condition 2: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2010/091/000586
- Lead Sponsor
- Ajanta Pharma Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
1. Patient with clinical diagnosis of chronic constipation
2. Written informed consent by patient participating in the trial
1. Adult patients <18 years of age of either sex
2. History of hypersensitivity to the study drug or related products
3. Significant history or presence of gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications
4. Any clinical significant illness during the 1 week prior to day 1 of this study
5. Participation in a clinical trial with an investigation drug within 30 days proceeding day 1 of this study
6. Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients having three or more spontaneous complete bowel movements per weekTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week
- Secondary Outcome Measures
Name Time Method Bowel movementTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Faecal strainingTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Global AssessmentTimepoint: 4th Week;Percentage of bowel movement with normal consistencyTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Percentage of patient with an average increase of SCBM per weekTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Safety and TolerabilityTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;Score of Abdominal PainTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week;status of fecesTimepoint: 0th Day, 1st Week, 2nd Week, 3rd Week, 4th Week