| CTRI Number |
CTRI/2023/09/057158 [Registered on: 01/09/2023] Trial Registered Prospectively |
| Last Modified On: |
11/08/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A pilot study to check the efficacy of Itopride Hydrochloride prolonged release capsule (Ganaton OD; 150 mg) in diabetic gastroparesis patients with dyspepsia |
|
Scientific Title of Study
|
A pilot study of Itopride Hydrochloride prolonged release capsule (Ganaton OD; 150 mg) in diabetic
gastroparesis patients with dyspepsia and alteration in ANMS GCSI – DD, electrogastrography (EGG) and nuclear
Scintigraphy parameters
|
| Trial Acronym |
EGG Study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ITPA-D22-0317; Version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sundeep Lakhtakia |
| Designation |
Director Endoscopy and EUS AIG Hospitals |
| Affiliation |
AIG Hospitals Hyderabad |
| Address |
No 136 Plot No 2 3 4 5 Survey 1 Mindspace Rd Gachibowli Hyderabad TELANGANA India
Hyderabad
TELANGANA
500032
India |
| Phone |
9848040629 |
| Fax |
|
| Email |
drsundeeplakhtakia@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sundeep Lakhtakia |
| Designation |
Director Endoscopy and EUS AIG Hospitals |
| Affiliation |
AIG Hospitals Hyderabad |
| Address |
No 136 Plot No 2 3 4 5 Survey 1 Mindspace Rd Gachibowli Hyderabad TELANGANA India
Hyderabad
TELANGANA
500032
India |
| Phone |
9848040629 |
| Fax |
|
| Email |
drsundeeplakhtakia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sundeep Lakhtakia |
| Designation |
Director Endoscopy and EUS AIG Hospitals |
| Affiliation |
AIG Hospitals Hyderabad |
| Address |
No 136 Plot No 2 3 4 5 Survey 1 Mindspace Rd Gachibowli Hyderabad TELANGANA India
Hyderabad
TELANGANA
500032
India |
| Phone |
9848040629 |
| Fax |
|
| Email |
drsundeeplakhtakia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Ltd.
Floor 16, Godrej BKC,
Plot No. C – 68, BKC,
Near MCA Club, Bandra (E)
Mumbai – 400 051 |
|
|
Primary Sponsor
|
| Name |
Abbott India Ltd. |
| Address |
Floor 16, Godrej BKC, Plot No. C – 68, BKC, Near MCA Club, Bandra (E) Mumbai – 400 051 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sundeep Lakhtakia |
AIG Hospital |
No 136 Plot No 2/3/4/5
Survey, 1, Mindspace
Rd Gachibowli, Hyderabad
TELANGANA
Hyderabad
TELANGANA |
9848040629
drsundeeplakhtakia@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Asian institute of Gastroenterology (IEC-AIG) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K319||Disease of stomach and duodenum, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ganaton OD; 150mg |
Itopride Hydrochloride Prolonged Release Capsule, Dose 150mg, administered after meal daily upto 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients from 18 to 70 years of age
Type I or Type II Diabetic patients with proven gastroparesis via nuclear scintigraphy
Patients having symptoms of dyspepsia as per ROME IV criteria. ROME IV criteria for Functional Dyspepsia Diagnostic criteria, one or more of the following
Bothersome postprandial fullness
Bothersome early satiation
Bothersome epigastric pain
Bothersome epigastric burning
Patient who has read the informed consent form, has understood the relevant aspects of the study, and grants his/her authorization to participate by signing the informed consent form before the inclusion in the study and the performance of any procedure
Patient willing to use appropriate method of contraception as per investigator’s discretion, throughout the study
No evidence of structural disease including at upper endoscopy that is likely to explain the symptoms
Must fulfil criteria for Postprandial Distress Syndrome (PDS) and/or Epigastric Pain Syndrome (EPS)
Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis
|
|
| ExclusionCriteria |
| Details |
Patients suffering from Diabetic Ketoacidosis.
Patients with history of any bariatric procedures/gastric surgeries in the past.
Females who are pregnant.
Patients taking following medications within 72 hours to the start of the study: Opioids, TCA, Calcium channel blockers, anti-psychotics, anti-cholinergic, steroids &L-Dopa.
Patients with electrolyte abnormalities like hypokalaemia & hypomagnesemia.
Patients with known cases of thyroid disorder (hypo or hyperthyroidism).
Patients who are unsuitable for any other reason to participate in the study in the opinion of the investigator
Pregnant or lactating women;
Patients with active gastroduodenal ulcer;
Patients with history of gastric, duodenal/esophageal surgery,
Patients with known hypersensitivity to the active substance
Those who had participated in any other investigational drug trial in preceding 4 weeks of first assessment.
Those on medications that effect gastrointestinal motility (e.g., prokinetics) 7 days prior to Baseline (Visit 2)
Those on medications that might interfere with the action of the study drug prior to the start of the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in mean ANMS GCSI-DD score from baseline to end of the treatment that is Day 90/ Visit 5
Number & proportion of patients & categorization as per socio demographic & clinical profile
Change in below EGG parameters at baseline versus Visit 5- Water load volume (water load satiety test)
Number and Percentage of patients with changes in gastric emptying using nuclear scintigraphy at baseline versus end of the treatment that is Day 90/ visit 5.
|
Baseline, Day 30, Day 60, Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Percentage frequency distribution of power in EGG in normogastria, bradygastria, tachygastrias, duodenal-respiration.
Power ratio - Ratio of post-prandial to fasting in DP. Dominant power (DP)
Number, severity & proportion of patients with adverse events (AEs) & serious adverse events (SAEs)
Change in laboratory parameters at baseline versus Visit 5
Change in the physical examination from baseline to Visit 5
Change in vital signs (pulse rate, systolic & diastolic blood pressure [SBP & DBP]) from baseline to Visit 5
Global tolerability assessment by patient & investigator from Visit 3 to Visit 5 graded on a 3-point scale ranging from “good tolerability (side effects may be mild or not observed)†to poor tolerability (side effects severe of discontinuation)â€
|
Baseline, Day 30, Day 60, Day 90 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/09/2023 |
| 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 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The
present study aims at evaluating the effect of Itopride Hydrochloride Prolonged
Release Capsule Hard (Ganaton OD; 150 mg) on altered gastrointestinal motility
according to symptomatic changes in patients suffering from Diabetic
gastroparesis with dyspepsia. ANMS, GCSI-DD score is a patient-based symptom
instrument used to assess the severity of gastroparesis-related symptoms. The
present study would also help to determine the importance of EGG in detecting
dyspepsia in DM patients thereby planning a proper treatment line for this
particular DM population. This pilot study would provide findings/abnormalities
seen in study population and may be helpful in providing proper treatment and a
better quality of life to DM patients suffering from dyspepsia. |