| CTRI Number |
CTRI/2024/09/074113 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A observational study of enzyme replacement therapy in people with diabetes and pancreas problems |
|
Scientific Title of Study
|
A Multicenter observational cohort study of use of PERT in patients with Pancretic Exocrine
Insufficiency with Type II Diabetes Mellitus in India |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Mr Mustafa Pardiwala |
| Designation |
Deputy General Manager – Clinical Operations |
| Affiliation |
Raptim Research private Ltd |
| Address |
A-242,A-226, TTC Industrial Area, Near Mahape Depot, Mahape MIDC, Navi Mumbai
Thane
MAHARASHTRA
400710
India |
| Phone |
9930275152 |
| Fax |
|
| Email |
mustafa.pardiwala@raptimresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jejoe Karankumar |
| Designation |
Director Medical Affairs |
| Affiliation |
Abbott India Ltd |
| Address |
16th Floor, Godrej BKC
Bandra (E)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
7045011810 |
| Fax |
|
| Email |
jejoe.karankumar@abbott.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani Acharya |
| Designation |
Director Clinical Development & Operation |
| Affiliation |
Abbott India Ltd, |
| Address |
16th Floor, Godrej BKC
Bandra (E)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
8657552543 |
| Fax |
|
| Email |
shivani.acharya@abbott.com |
|
|
Source of Monetary or Material Support
|
| Abbott India Limited, 16th Floor, Godrej BKC Bandra (E)
Mumbai, MAHARASHTRA
400051
India |
|
|
Primary Sponsor
|
| Name |
Abbott India Ltd |
| Address |
16th Floor, Godrej BKC Bandra (E)
Mumbai
MAHARASHTRA
400051
India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vismay Naik |
Ashirwad Multispeciality Hospital |
B-301, Shaligram Lakeview Commercial, Vaishnodevi circle, Tragad,382210 India
Ahmadabad
GUJARAT |
9909929795
vismay101@gmail.com |
| Dr Vaishali Chetan Deshmukh |
Deshmukh Clinic and Research Centre |
2nd floor, Pinnacle Prestige, 1169, Sadashiv Peth, Tilak Road, 411030. Opposite Maharashtra Electronics, Above Cosmos bank, Near Durvankur Hotel.
Pune
MAHARASHTRA |
9850811450
drvaishaliresearch@gmail.com |
| Dr Jothydev Kesavadev |
Jothydevs Diabetes Research Centre |
JDC Junction, Mudavan mugal-Konkalam Road, Department of Clinical Research, Research unit, Room No: 25 695032 India
Thiruvananthapuram
KERALA |
9895040055
jothydev@gmail.com |
| Dr Alok Kanungo |
Kanungo Institute of Diabetes Specialities |
Plot no-1120, Dumduma, Bhubaneswar-751019
Khordha
ORISSA |
9437055740
kanungokids@gmail.com |
| Dr Amol Dange |
Lifepoint Multispeciality Hospital |
145/1, Third floor, Research department,Mumbai-Banglore Highway, Near HotelSayaji, Wakad, Pune, 411057
Pune
MAHARASHTRA |
9823912040
amoldange298@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Central Independent Ethics Committee CIEC |
Approved |
| Ethics Committee, Jothydevs Diabetes Research Centre |
Approved |
| KIDS Ethics Committee |
Approved |
| Lifepoint Research Ethics Committee |
Approved |
| Sangini hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K868||Other specified diseases of pancreas, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Pancreatin enteric-coated capsule 10000 U lipase |
Amylase 8000 (Ph.Eur.U)/U
Lipase 10000 (Ph.Eur.U)/U
Protease 600 (Ph.Eur.U)/U
Route of administration: Pancreatin capsule — Oral
The treatment
observation duration will be 30 days |
| Intervention |
Pancreatin enteric-coated capsule 25000 U lipase |
Amylase 18000 (Ph.Eur.U)/U
Lipase 25000 (Ph.Eur.U)/U
Protease 1000 (Ph.Eur.U)/U
Route of administration: Pancreatin capsule — Oral The treatment observation duration will be 30 days |
| Intervention |
Pancreatin enteric-coated capsule 40000 U lipase |
Pancreatin Minimicrospheres equivalent to Pancreatin IP 400 mg
Route of administration: Pancreatin capsule — Oral The treatment observation duration will be 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients meeting all the following criteria are eligible for participation in the study:
1. Male or female adult patients aged 18 years to 65 years.
2. Known case of T2DM with confirmed diagnosis of PEI based on clinical and biochemical assessment (meeting both of following criteria)
a. Biochemical diagnosis will be based on criteria with patients meeting FE-1 values less than 200 μg/g.
b. Symptomatic diagnosis will be based on presence of any of the following symptoms: steatorrhea, abdominal pain, weight loss, diarrhea, bloating, and foul-smelling and greasy stools.
3. Patient prescribed Pancreatin enteric-coated capsule as per approved label.
4. Patient willing to give written informed consent to participate into the study.
5. Willing to take the study drug as prescribed by the investigator.
6. Willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
A patient will be excluded from the study if they meet any of the following criteria:
1. Patients requiring hospitalization due to severe nature of disease.
2. Patients with severe cardiac, renal or hepatic disease
3. Malignancy involving the digestive tract in the past 5 years
4. Patients who have recently undergone major surgery (excluding appendectomy or gall-bladder removal).
5. Contraindications to PERT treatment, including hypersensitivity to active substance, porcine proteins, pancreatin or any ingredient.
6. Use of any PERT within 30 days prior to study enrollment
7. Women of childbearing potential with a positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study.
8. Any condition or unsuitable reasons that in the opinion of the investigator does not justify the patient’s inclusion in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The change in mean abdominal symptom score on the PEI-Q will be summarized at Day 30 using descriptive measures as well as 95 percent CI of the mean. A paired t-test (if data normal) or Wilcoxon signed-rank test will be performed at the 5 percent level to assess the significance of the change from baseline |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The change in mean abdominal symptom score at Day 15 and change
in mean bowel movement symptom score on the PEI-Q at Days 15 and 30 will be analyzed
in the same manner as the primary endpoint. |
30 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
1.Primary Objective • To evaluate the effectiveness of Pancreatin enteric-coated capsule on improvement in abdominal symptoms like abdominal pain and bloating at day 30 of treatment in patients of PEI with T2DM. 2. Secondary Objective(s) • To evaluate the effectiveness of Pancreatin enteric-coated capsule on improvement in abdominal symptoms like abdominal pain and bloating at day 15 of treatment in patients of PEI with T2DM. • To evaluate the effectiveness of Pancreatin enteric-coated capsule on improvement in bowel movement symptoms like stool frequency, form, and consistency at day 15 and day 30 of treatment in patients of PEI with T2DM. 3.Safety Objectives: • Evaluate safety of Pancreatin enteric-coated capsule in T2DM patients. |