Clinical study of to Compare the Efficacy and Safety of EVAQ Syrup (Lactitol Monohydrate) with Duphalac Syrup (Lactulose) in the Treatment of Constipation in Adults.
- Registration Number
- CTRI/2010/091/001416
- Lead Sponsor
- MEDLEY PHARMACEUTICALS LTD.D-2,MIDC,MEDLEY HOUSE,ANDHERI (E)MUMBAI-400093
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Patients suffering from constipation (fewer than three BMs a week) for at least three months and are in need of regular laxatives such as cremaffin, liquid paraffin.
Constipation as defined by the American College of Gastroenterology (ACG): Unsatisfactory defecation characterized by infrequent stools, difficult stool passage, or both. Difficult stool passage includes straining, a sense of difficulty passing stool, incomplete evacuation, hard/lumpy stools, prolonged time to stool, or need for manual maneuvers to pass stool.
Men and non-pregnant women 18 to 60 years of age
Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving any study drug.
Ambulatory patients who do not require hospital admission at the time of entry into the study
Patient who is able and willing to complete a daily diary card.
Patients suffering from hepatic encephalopathy
Patients with known/suspected history of hypersensitivity to any of the trial drugs
Patients with known history of colorectal cancer, anal abscess, anal fistula, anal fissure, rectocele, inflammatory bowel diseases, or gastrointestinal obstruction
Patients with a known history of diabetes, hypertension, hypothyroidism, or any other metabolic disorders
Patients with unknown cause of gastrointestinal bleeding, or acute infection
Patients with symptoms of appendicitis or recent intestinal surgery
Patients whose chronic constipation, according to the investigator's clinical judgment, is thought to be a result of: bowel surgery, gynecological surgery, neurologic disorders (e.g., aganglionosis, hypoganglionosis, autonomic neuropathy, Parkinson's disease, spinal cord injury or tumor, cerebrovascular accidents, multiple sclerosis), systemic sclerosis, myloidosis, scleroderma, myotonic dystrophy
Pregnant or lactating women
Patients, who within the past 30 days have participated in an investigational clinical study
Drug induced constipation
Patients taking prokinetic drugs e.g., Itopride, domperidone
Patients taking anti-hypertensive drugs like calcium channel blockers, beta-blockers, or patients taking calcium supplements
Patients with a history of drug abuse
Patients with a history of any psychiatric disorders
Patients with known severe renal or hepatic insufficiency, cardiac diseases
Patients, who in the opinion of the investigator should not be included in the study for any reason, including inability to follow study procedures or for whom the change in prescription of laxatives is not required.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency of bowel movements (BM) per day<br>Stool consistency<br>Ease of evacuation <br>Time taken to get first bowel evacuationTimepoint: 3,6,9 and 12 days
- Secondary Outcome Measures
Name Time Method Requirement of the dose increment in patients<br>Global assessment by the physician and the patient ? patients? and physicians? recorded improvement score and palatability criteria evaluated based on the visual analogue scale (VAS) by the patient.<br>Quality of Life Questionnaire (QoL) ? PAC-QoL<br>Timepoint: 3,6,9 and 12 days