| CTRI Number |
CTRI/2023/04/052031 [Registered on: 27/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
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Public Title of Study
|
Placebo control study of lansoprazole for the treatment of functional dyspepsia in children
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Scientific Title of Study
|
Double blind randomized placebo control study of lansoprazole for the treatment of functional dyspepsia in children
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| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Saif Chaudhary |
| Designation |
Junior resident |
| Affiliation |
Eras lucknow medical college |
| Address |
Pediatrics OPD (Room 3) , 1st floor , Hospital Building
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8090596570 |
| Fax |
|
| Email |
drsaifchaudhary@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shrish Bhatnagar |
| Designation |
Professor |
| Affiliation |
Eras lucknow medical college |
| Address |
Department of pediatrics, 2nd Floor , hospital building ,Eras Lucknow medical college and hospital Sarfarazganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9918208555 |
| Fax |
|
| Email |
drshrishbhatnagar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mohammad Saif Chaudhary |
| Designation |
Junior resident |
| Affiliation |
Eras lucknow medical college |
| Address |
Eras Lucknow medical college and hospital Sarfarazganj Lucknow
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8090596570 |
| Fax |
|
| Email |
drsaifchaudhary@gmail.com |
|
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Source of Monetary or Material Support
|
| Fourrts pharmaceutical company |
|
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Primary Sponsor
|
| Name |
Fourrts pharmaceutical company |
| Address |
Fourrts laboratories pvt limited , 1 Fourrts Avenue, Anna Indra Nagar, Okkiyam Thoraipakkam , Chennai , India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Mohammad Saif Chaudhary |
Eras Lucknow medical college |
Department of paediatrics , IPD and OPD (Room no.3)
Lucknow
UTTAR PRADESH |
8090596570
drsaifchaudhary@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee , Era’s Lucknow medical college and hospital , lucknow |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K30||Functional dyspepsia, |
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Lansoprazole, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 15(mg), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: NA, Route: NA, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
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Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
FUNCTIONAL DYSPEPSIA (Roams 4 criteria) -
Must include one or more of the following bothersome symptoms at least 4 times a month for at least 2 months prior to diagnosis:
Postprandial fullness
Early satiation
Epigastric pain or burning not associated with defecation
After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
Within FD(Functional dyspepsia) the following subtypes are now adopted:
H2a1.  Postprandial distress syndrome includes bothersome postprandial fullness or early satiation which prevents finishing a regular meal. Supportive features include upper abdominal bloating, postprandial nausea, or excessive belching.
H2a2.  Epigastric pain syndrome which includes all of the following: bothersome (severe enough to interfere with normal activities) pain or burning localized to the epigastrium. The pain is not generalized or localized to other abdominal or chest regions and is not relieved by defecation or passage of flatus. Supportive criteria can include (a) burning quality of the pain but without a retrosternal component, (b) commonly induced or relieved by ingestion of a meal but may occur while fasting.
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| ExclusionCriteria |
| Details |
1.Patient already on treatment with Proton pump inhibitors (PPI) /H2RA, Prokinetics ,NSAIDS or within 1 week of study commencement
2.Previous Gastrointestinal surgery and diseases (e.g. – ulcerative colitis, crohn’s disease)
3.Chronic systemic illness (liver,heart,renal diseases)
4.History of H. Pylori infection and treatment in last 6 months
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of lansoprazole vs placebo on participants for complete relief of epigastric pain and postprandial distress during the last 3 days of 4 week treatment
|
28 days |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1).Relief from other gastrointestinal symptoms like : nausea ,upper abdominal bloating , excessive belching , heartburn at day 7 , 14 and 28
2).Evaluate the participants at day 7 and 14 for complete relief of epigastric pain and postprandial distress i.e. early improvement
|
day 7 ,day 14 ,day 28 |
|
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Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
05/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
none yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 24-04-2023 and end date provided 30-05-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
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Brief Summary
|
•Functional dyspepsia is one of the common functional gastrointestinal disorders with prevalence of 10-20% . •Impaired gastric accommodation reflex, food allergy, delayed gastric emptying, post viral gastroparesis are some of the causes attributed to the etiology •Genetic predisposition and psychiatric comorbidity may also play role to some extent .
DIAGNOSTIC CRITERIA [ROME IV]- FUNCTIONAL DYSPEPSIA - Must include one or more of the following bothersome symptoms at least 4 times a month for at least 2 months prior to diagnosis: •Postprandial fullness •Early satiation •Epigastric pain or burning not associated with defecation •After appropriate evaluation, the symptoms cannot be fully explained by another medical condition Within FD(Functional dyspepsia) the following subtypes are now adopted: •H2a1. Postprandial distress syndrome includes bothersome postprandial fullness or early satiation which prevents finishing a regular meal. Supportive features include upper abdominal bloating, postprandial nausea, or excessive belching. •H2a2. Epigastric pain syndrome which includes all of the following: bothersome (severe enough to interfere with normal activities) pain or burning localized to the epigastrium. The pain is not generalized or localized to other abdominal or chest regions and is not relieved by defecation or passage of flatus. Supportive criteria can include (a) burning quality of the pain but without a retrosternal component, (b) commonly induced or relieved by ingestion of a meal but may occur while fasting. Research questions - •Is 4 week treatment regime of lansoprazole more effective than placebo in alleviating the symptoms of functional dyspepsia in children ?
PRIMARY OBJECTIVE – To compare the effect of lansoprazole vs placebo on participants for complete relief of epigastric pain and postprandial distress during the last 3 days of 4 week treatment • SECONDARY OBJECTIVE – •Relief from other gastrointestinal symptoms like :nausea ,upper abdominal bloating , excessive belching , heartburn at day 7 , 14 and 28 • Evaluate the participants at day 7 and 14 for complete relief of epigastric pain and postprandial distress i.e. early improvement Inclusion criteria -•Inclusion is based on the Rome IV criteria for functional dyspepsia [age 4 to 18 years ] Exclusion criteria -•Patient already on treatment with Proton pump inhibitors (PPI) /H2RA, Prokinetics ,NSAIDS or within 1 week of study commencement •Previous Gastrointestinal surgery and diseases (e.g. – ulcerative colitis, crohn’s disease) •Chronic systemic illness (liver,heart,renal diseases) •History of H. Pylori infection and treatment in last 6 months
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