An Open label Prospective Non Comparative Phase III Study for Efficacy and Safety of FDC of Ispaghula Husk IP 3.5g and Lactitol Monohydrate BP 10g Granules, in the treatment of Acute Idiopathic Constipation.
- Conditions
- Health Condition 1: null- Acute Idiopathic Constipation
- Registration Number
- CTRI/2010/091/001106
- Lead Sponsor
- Akums Drugs Pharmaceuticals Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Subjects of both sexes , aged between 18-50 years
Subjects with acute idiopathic constipation(defined as presence of less than three stools per week and/or straining at stool for at least three months) who have one or more of the following symptoms associated with at least 25% of bowel movements (BMs) for at least 3 months prior to the baseline visit: very hard (little balls) and/or hard stools, a sensation of incomplete evacuation, or straining at defecation.
Documented mechanical obstruction, megacolon/megarectum or a diagnosis of pseudoobstruction
Hypersensitivity to lactitol, Ispaghula Husk or any other constituents of the investigational product.
Known or suspected organic disorders of the large or small intestine.
Secondary causes of constipation.
Hospitalization for any gastrointestinal or abdominal surgical procedure during the 3 months before the start of the study.
Prior bowel resection.
Clinically significant cardiovascular, liver, lung, or other systemic disease; neurologic or psychiatric disorders.
Cancer within the past 5 yr
Women of childbearing potential who cannot use oral or implanted contraceptives or to have used a double-barrier method during the trial.
Breast feeding women.
Any other illness which could seriously effect the safety of subjects and /or the integrity of the study
Subjects who, within the past 30 days have participated in an investigational clinical study.
Subjects currently taking, or planning to take any of the following medications that are known to effect bowel habits:
Antidiarrheals
Antacids containing magnesium or aluminum salts
Anticholinergics
Antispasmodic agents
Erythromycin and other macrolides
Opiods/narcotic analgesics
Prokinetics
Serotonin re-uptake inhibitors or tricyclic antidepressants
Calcium antagonists.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method