Status:
WITHDRAWN
Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome
Lead Sponsor:
Tehran University of Medical Sciences
Collaborating Sponsors:
Tillotts Pharma AG
Conditions:
Diarrhea- Predominant Irritable Bowel Syndrome
Quality of Life
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The aim of this study is to evaluate the effects of Mesalamine and Amitriptyline drugs on the Quality of Life and Symptom Severity Scale in patients with Diarrhea- Predominant Irritable Bowel Syndrome...
Eligibility Criteria
Inclusion
- Establishment of diagnosis of IBS by ROME-III criteria
- Age \> 18 years old and \< 65 years old
- Normal colonoscopy or sigmoidoscopy
- Negative celiac serologic markers
- Normal complete blood count (CBC) and stool exam and stool culture
- The patient should not be administered Anti-inflammatory drugs such as Nonsteroidal Antiinflammatory Drugs(NSAIDs), oral or parenteral Antibiotics, Corticosteroids, Mast cell stabilizers, Narcotics, Antidepressants and Immunosuppressive Agents.
- Normal thyroid-stimulating hormone (TSH )
- Normal Serum Calcium
- Educated patient
Exclusion
- Breast feeding and Pregnancy
- Presence of acute or chronic inflammation which can change the basal level of cytokines
- Allergic disorders like Asthma (family and personal history)
- Presence of organic disease like Diabetes mellitus or Psychiatric disorders.
- Alcohol dependency and addiction to Tobacco and Opium
- Patients who do not use efficient contraception method
- History of extensive abdominopelvic surgery except Appendectomy, Cholecystectomy, Hysterectomy and Cesarian-Section
- Presence of Celiac disease
- History of Crohn's disease, Ulcerative Colitis and Diverticulitis during the previous year.
- History of Cardiac, Pulmonary, Hepatic and Renal disease
- Presence of chronic GI disorders
- History of Allergy to Aspirin, Mesalamine or Sulpha compounds
- History of Lymphocytic or Microscopic Colitis
- History of significant weight loss ( 10% of body weight during 6 months), nocturnal sweating, GI bleeding and family history of Colon cancer
- Patients with Lactose intolerance disease
- Presence of Bowel Acid Malabsorption
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02190526
Start Date
September 1 2014
End Date
December 1 2015
Last Update
April 15 2016
Active Locations (1)
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1
Gastrointestinal Private Clinic
Tehran, Tehran Province, Iran