- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02190526
Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome
Therapeutic Effects of Mesalamine and Amitriptyline in IBS: a Randomized Clinical Trial
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 (IBS-D).
All patients will fill three validated questionnaires (IBS Symptom Severity Scale (IBS-SSS) , Hospital Anxiety and Depression Scale (HADS ) and IBS Quality of Life (IBS-QOL) ) at the beginning of trial and at weeks 2,4,6 and 8 of treatment.
Serum Immune Bio markers will be measured at 0,4, and 8 weeks of treatment. This study is a clinical trial upon 90 patients with Diarrhea- Predominant IBS (IBS-D) who are referred for the first time to our private gastrointestinal clinic from 2014 until 2016.
All patients who meet the inclusion criteria enrolled for a 2-week period screening phase. In order to exclude patients with Lactose intolerance, all patients take a lactose-free diet for 14 days before inclusion and patients whose symptoms improve by this regimen will be excluded.
This trial is a double-blind study and all patients will be assigned randomly to three groups:
- Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to Amitriptyline (10 mg/HS) for 8 weeks
- Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like Asacol (800 mg/ TDS) for 8 weeks
- Control group (placebo group): Patients receive placebo like Asacol (800 mg/TDS) and placebo similar to Amitriptyline (10 mg/HS) for 8 weeks
Ethical considerations:
- All patients will fulfill an informed consent
- Drugs are available without any charge
- Observation of Helsinki ethical statement
Study Overview
Status
Intervention / Treatment
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Tehran, Iran, Islamic Republic of
- Gastrointestinal Private Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mesalazine(asacol 800 mg)
patients receive asacol (800 mg/TDS) and a placebo agent similar to amitriptyline (10 mg/HS) for 8 weeks
|
|
Experimental: Amitriptyline
patients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks
|
|
Placebo Comparator: placebo group
patients receive placebo like asacol (800 mg/TDS) and placebo similar to amitriptyline (10 mg/HS) for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life
Time Frame: 1 year
|
All patients will fill three validated questionnaires (IBS-SSS , HADS and IBS-QOL ) at the beginning of trial and at weeks 2,4,6 and 8 of treatment to assess quality of life and symptom severity scale in patients with diarrhea- predominant .
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum immune biomarkers
Time Frame: 1 year
|
Serum immune biomarkers will be measured at 0,4, and 8 weeks of treatment.
|
1 year
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Nasser Ebrahimi Daryani, Professor, tehran university of medical science
- Principal Investigator: Zahra Azizi, Researcher, Iran University of Medical Sciences
- Study Director: Mohammad Bashashati, Research Associate, University of Calgary
- Study Director: Nima Rezaei, Assistant Professor, tehran university of medical science
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Diarrhea
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Antidepressive Agents, Tricyclic
- Adrenergic Uptake Inhibitors
- Amitriptyline
- Mesalamine
Other Study ID Numbers
- 8811215278
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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