Diarrhea- Predominant Irritable Bowel SyndromePhase 4NCT02190526
Effects of Mesalamine and Amitriptyline on Irritable Bowel Syndrome
A Phase 4 study testing Mesalazine(asacol 800 mg) and Amitriptyline in people with Diarrhea- Predominant Irritable Bowel Syndrome and Quality of Life, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diarrhea- Predominant Irritable Bowel Syndrome, Quality of Life
- What is being tested?
- Mesalazine(asacol 800 mg) and Amitriptyline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteIran
- Study dates
- Sep 2014to Dec 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Normal thyroid-stimulating hormone (TSH )
- Normal Serum Calcium
- Educated patient
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Mesalazine(asacol 800 mg), Amitriptyline, placebo like asacol, placebo like amitriptyline
- Keywords
- mesalamine, amitriptyline, Severity of Illness Index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesalazine(asacol 800 mg)Drug
AmitriptylineDrug
placebo like asacolDrug
placebo like amitriptylineDrug
| Study group | Role | What they receive |
|---|---|---|
| Mesalazine(asacol 800 mg) | Experimental | patients receive asacol (800 mg/TDS) and a placebo agent similar to amitriptyline (10 mg/HS) for 8 weeks Receives: Drug: Mesalazine(asacol 800 mg); Drug: placebo like amitriptyline |
| Amitriptyline | Experimental | patients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks Receives: Drug: Amitriptyline; Drug: placebo like asacol |
| placebo group | Placebo comparator | patients receive placebo like asacol (800 mg/TDS) and placebo similar to amitriptyline (10 mg/HS) for 8 weeks Receives: Drug: placebo like asacol; Drug: placebo like amitriptyline |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
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 .
Measured: 1 year
Secondary outcomes (1)
Serum immune biomarkers
Serum immune biomarkers will be measured at 0,4, and 8 weeks of treatment.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Study stopped due to lack of volunteer patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diarrhea- Predominant Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Tillotts Pharma AG
- Responsible party
- Sponsor
- Investigators
- Nasser Ebrahimi Daryani, Professor, Study director, Tehran University of Medical ScienceZahra Azizi, Researcher, Principal investigator, Iran University of Medical SciencesMohammad Bashashati, Research Associate, Study director, University of CalgaryNima Rezaei, Assistant Professor, Study director, Tehran University Of Medical Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190526
- Sponsor's protocol ID
- 8811215278
- Status last verified
- Apr 2016
- First submitted
- 27 Mar 2014
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Mesalamine and Amitriptyline in IBS: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02190526
- Acronym / sponsor ID
- 8811215278
- Keywords
- mesalamine, amitriptyline, Severity of Illness Index
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study stopped due to lack of volunteer patients.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Tillotts Pharma AG
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mesalazine(asacol 800 mg) | Experimental | Drug: Mesalazine(asacol 800 mg), Drug: placebo like amitriptylinepatients receive asacol (800 mg/TDS) and a placebo agent similar to amitriptyline (10 mg/HS) for 8 weeks |
| Amitriptyline | Experimental | Drug: Amitriptyline, Drug: placebo like asacolpatients receive amitriptyline (10 mg/HS) and a placebo like asacol (800 mg/ TDS) for 8 weeks |
| placebo group | Placebo comparator | Drug: placebo like asacol, Drug: placebo like amitriptylinepatients receive placebo like asacol (800 mg/TDS) and placebo similar to amitriptyline (10 mg/HS) for 8 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesalazine(asacol 800 mg) | Drug | Mesalazine(asacol 800 mg) |
| Amitriptyline | Drug | Amitriptyline |
| placebo like asacol | Drug | Amitriptyline, placebo group |
| placebo like amitriptyline | Drug | Mesalazine(asacol 800 mg), placebo group |
Primary outcome
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 secondary outcome
Serum immune biomarkers
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
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Clinical Efficacy and Safety of Jingfang Granules in Treating Diarrhea-Predominant Irritable Bowel Syndrome With Cold-Dampness Disturbing Spleen Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nasser Ebrahimi Daryani, Professor study director
Tehran University of Medical Science
Zahra Azizi, Researcher principal investigator
Iran University of Medical Sciences
Mohammad Bashashati, Research Associate study director
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mesalazine(asacol 800 mg) and Amitriptyline in people with Diarrhea- Predominant Irritable Bowel Syndrome and Quality of Life, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2016.