Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome

• Sponsor: Tehran University of Medical Sciences (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT02190526
• Collaborator: Tillotts Pharma AG (Industry)
• Enrollment: 0
• Location: 1
• Arms: 3
• Duration (Months): 15
• Patients Per Site Per Month: 0

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Sep 1, 2014
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. quality of life [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 [1 year]

   Serum immune biomarkers will be measured at 0,4, and 8 weeks of treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastrointestinal Private Clinic	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

• Tehran University of Medical Sciences
• Tillotts Pharma AG

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tehran University of Medical Sciences
• ClinicalTrials.gov Identifier: NCT02190526
• Other Study ID Numbers: 8811215278
• First Posted: Jul 15, 2014
• Last Update Posted: Apr 15, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Tehran University of Medical Sciences: mesalamine; amitriptyline; Severity of Illness Index
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea; Mesalamine; Amitriptyline

Study Results

No Results Posted as of Apr 15, 2016