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Trial record 16 of 135 for:    AMITRIPTYLINE

Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

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ClinicalTrials.gov Identifier: NCT02190526
Recruitment Status : Withdrawn (Study stopped due to lack of volunteer patients.)
First Posted : July 15, 2014
Last Update Posted : April 15, 2016
Sponsor:
Collaborator:
Tillotts Pharma AG
Information provided by (Responsible Party):
Tehran University of Medical Sciences

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 (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:

  1. Mesalazine group: Patients receive Asacol (800 mg/TDS) and a placebo agent similar to Amitriptyline (10 mg/HS) for 8 weeks
  2. Amitriptyline group: Patients receive Amitriptyline (10 mg/HS) and a placebo like Asacol (800 mg/ TDS) for 8 weeks
  3. 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:

  1. All patients will fulfill an informed consent
  2. Drugs are available without any charge
  3. Observation of Helsinki ethical statement

Condition or disease Intervention/treatment Phase
Diarrhea- Predominant Irritable Bowel Syndrome Quality of Life Drug: Mesalazine(asacol 800 mg) Drug: Amitriptyline Drug: placebo like asacol Drug: placebo like amitriptyline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Therapeutic Effects of Mesalamine and Amitriptyline in IBS: a Randomized Clinical Trial
Study Start Date : September 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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
Drug: Mesalazine(asacol 800 mg)
Drug: placebo like amitriptyline
Experimental: Amitriptyline
patients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks
Drug: Amitriptyline
Drug: placebo like asacol
Placebo Comparator: placebo group
patients receive placebo like asacol (800 mg/TDS) and placebo similar to amitriptyline (10 mg/HS) for 8 weeks
Drug: placebo like asacol
Drug: placebo like amitriptyline



Primary Outcome Measures :
  1. 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 .


Secondary Outcome Measures :
  1. Serum immune biomarkers [ Time Frame: 1 year ]
    Serum immune biomarkers will be measured at 0,4, and 8 weeks of treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Establishment of diagnosis of IBS by ROME-III criteria
  2. Age > 18 years old and < 65 years old
  3. Normal colonoscopy or sigmoidoscopy
  4. Negative celiac serologic markers
  5. Normal complete blood count (CBC) and stool exam and stool culture
  6. 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.
  7. Normal thyroid-stimulating hormone (TSH )
  8. Normal Serum Calcium
  9. Educated patient

Exclusion Criteria:

  1. Breast feeding and Pregnancy
  2. Presence of acute or chronic inflammation which can change the basal level of cytokines
  3. Allergic disorders like Asthma (family and personal history)
  4. Presence of organic disease like Diabetes mellitus or Psychiatric disorders.
  5. Alcohol dependency and addiction to Tobacco and Opium
  6. Patients who do not use efficient contraception method
  7. History of extensive abdominopelvic surgery except Appendectomy, Cholecystectomy, Hysterectomy and Cesarian-Section
  8. Presence of Celiac disease
  9. History of Crohn's disease, Ulcerative Colitis and Diverticulitis during the previous year.
  10. History of Cardiac, Pulmonary, Hepatic and Renal disease
  11. Presence of chronic GI disorders
  12. History of Allergy to Aspirin, Mesalamine or Sulpha compounds
  13. History of Lymphocytic or Microscopic Colitis
  14. History of significant weight loss ( 10% of body weight during 6 months), nocturnal sweating, GI bleeding and family history of Colon cancer
  15. Patients with Lactose intolerance disease
  16. Presence of Bowel Acid Malabsorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190526


Locations
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Iran, Islamic Republic of
Gastrointestinal Private Clinic
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Tehran University of Medical Sciences
Tillotts Pharma AG
Investigators
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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

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Responsible Party: Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02190526     History of Changes
Other Study ID Numbers: 8811215278
First Posted: July 15, 2014    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Keywords provided by Tehran University of Medical Sciences:
mesalamine
amitriptyline
Severity of Illness Index
Additional relevant MeSH terms:
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Amitriptyline
Amitriptyline, perphenazine drug combination
Irritable Bowel Syndrome
Syndrome
Diarrhea
Disease
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mesalamine
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Antipsychotic Agents