Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-02-25 @ 11:03 PM
Study NCT ID:
NCT07008235
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2025-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-06', 'studyFirstSubmitDate': '2025-05-24', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in dyspeptic symptom', 'timeFrame': 'At baseline and then at week 4,8, and 12 after randomization', 'description': 'The improvement of dyspeptic symptoms will be assessed by a 5-point Likert Scale titled "Patient dyspeptic symptom score". There are four main symptoms of dyspepsia, each graded as 1,2,3,4,5. The total minimum value is 1 and maximum value is 20. Higher score means worse outcome.'}], 'secondaryOutcomes': [{'measure': 'See the effect of trifluoperazine', 'timeFrame': 'At baseline and then at week 4,8, and 12 after randomization', 'description': 'Effect of trifluoperazine on dyspeptic symptoms will be assessed by a 5-point Likert Scale titled "Patient dyspeptic symptom score". There are four main symptoms of dyspepsia, each graded as 1,2,3,4,5. The total minimum value is 1 and maximum value is 20. Higher score means worse outcome.'}, {'measure': 'See the effect of amitriptyline', 'timeFrame': 'At baseline and then at week 4,8, and 12 after randomization', 'description': 'Effect of amitriptyline on dyspeptic symptoms will be assessed by a 5-point Likert Scale titled "Patient dyspeptic symptom score". There are four main symptoms of dyspepsia, each graded as 1,2,3,4,5. The total minimum value is 1 and maximum value is 20. Higher score means worse outcome.'}, {'measure': 'Compare the effects of amitriptyline and trifluoperazine', 'timeFrame': 'At baseline and then at week 4,8, and 12 after randomization', 'description': 'Effect of amitriptyline and trifluoperazine on dyspeptic symptoms will be assessed and compared by a 5-point Likert Scale titled "Patient dyspeptic symptom score". There are four main symptoms of dyspepsia, each graded as 1,2,3,4,5. The total minimum value is 1 and maximum value is 20. Higher score means worse outcome.'}, {'measure': 'Adverse events', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Patient reported adverse events will be documented'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional Dyspepsia', 'Amitriptyline', 'Trifluoperazine'], 'conditions': ['Functional Dyspepsia']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. The main questions it aims to answer are:\n\nDoes drug amitriptyline and trifluoperazine has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug amitriptyline and trifluoperazine? Researcher will compare drug amitriptyline and trifluoperazine to a control group taking standard first line treatment only.\n\nParticipants will:\n\nTake drug amitriptyline 10 milligrams at night or trifluoperazine 1 milligrams twice daily every day for 8 weeks along with standard first line treatment. A third group will be taken as control arm who will be kept on standard first line treatment only for 8 weeks. After that all three groups will be kept only on standard first line treatment for an additional 4 weeks. They will visit the hospital 4 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 4, 8, and 12. Additionally, patient reported adverse events will be documented.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or more\n* Patients with FD diagnosed according to ROME IV criteria\n* Patients who are willing to sign informed written consent\n\nExclusion Criteria:\n\n* Structural lesion in endoscopy and positive CLO test\n* Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms\n* History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease\n* Major medical and psychiatric disorders\n* Previous history gastrointestinal surgery\n* Any patient with ongoing treatment with antidepressants or antipsychotics\n* Any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine\n* Patients for whom Amitriptyline and Trifluoperazine are contraindicated\n* Elderly patients\\> 60 years\n* Pregnancy and breastfeeding'}, 'identificationModule': {'nctId': 'NCT07008235', 'briefTitle': 'Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Dhaka Medical College'}, 'officialTitle': 'Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia', 'orgStudyIdInfo': {'id': 'IRB-DMC/2025/38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Amitriptyline', 'description': 'Tab. Amitriptyline 10 milligrams at night', 'interventionNames': ['Drug: Tablet Amitriptyline 10 milligrams']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Trifluoperazine', 'description': 'Tab. Trifluoperazine 1 milligrams twice daily', 'interventionNames': ['Drug: Tablet Trifluoperazine 1 milligrams twice daily']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'First line treatment only'}], 'interventions': [{'name': 'Tablet Amitriptyline 10 milligrams', 'type': 'DRUG', 'description': 'Tablet Amitriptyline 10 milligrams at night will be given to patients along with standard first line treatment of functional dyspepsia', 'armGroupLabels': ['Amitriptyline']}, {'name': 'Tablet Trifluoperazine 1 milligrams twice daily', 'type': 'DRUG', 'description': 'Tablet Trifluoperazine 1 milligrams twice daily will be given to patients along with standard first line treatment of functional dyspepsia', 'armGroupLabels': ['Trifluoperazine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Dhaka', 'status': 'RECRUITING', 'country': 'Bangladesh', 'contacts': [{'name': 'Md. Moktadirul Hoque Shuvo, MBBS', 'role': 'CONTACT', 'email': 'kdshuvo1430@gmail.com', 'phone': '+8801788450963'}], 'facility': 'Dhaka Medical College', 'geoPoint': {'lat': 23.7104, 'lon': 90.40744}}], 'centralContacts': [{'name': 'Md. Moktadirul Hoque Shuvo, MBBS', 'role': 'CONTACT', 'email': 'kdshuvo1430@gmail.com', 'phone': '+8801788450963'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Md. Moktadirul Hoque Shuvo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Md. Moktadirul Hoque Shuvo', 'investigatorAffiliation': 'Dhaka Medical College'}}}}