| CTRI Number |
CTRI/2024/04/065083 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years |
|
Scientific Title of Study
|
An exploratory, multicenter, randomized, double blind study of clinical outcomes, tolerability, and safety of 2 doses of oral pantoprazole in pediatric participants aged 1 to 11 years and 12 to 17 years who require maintenance therapy for healed erosive esophagitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2020-005030-15 |
EudraCT |
| B1791094 (Protocol Amendment 3 Final 06 October 2022) |
Protocol Number |
| NCT04821310 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Pai |
| Designation |
Director-Clinical Site Operations |
| Affiliation |
Pfizer Limited |
| Address |
Global Site and Study Operations, Clinical Development and Operations, Global Product Development, Pfizer Limited, The Capital, 1802/1901, Plot No. C 70, G Block, BKC, Bandra(E)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
918826422322 |
| Fax |
|
| Email |
seema.pai@pfizer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Pai |
| Designation |
Director-Clinical Site Operations |
| Affiliation |
Pfizer Limited |
| Address |
Global Site and Study Operations, Clinical Development and Operations, Global Product Development, Pfizer Limited, The Capital, 1802/1901, Plot No. C 70, G Block, BKC, Bandra(E)
Mumbai
MAHARASHTRA
400051
India |
| Phone |
918826422322 |
| Fax |
|
| Email |
seema.pai@pfizer.com |
|
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Source of Monetary or Material Support
|
| Pfizer Inc., 66 Hudson Boulevard East, New York, NY 10001, USA |
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Primary Sponsor
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| Name |
Pfizer Inc., |
| Address |
66 Hudson Boulevard East, New York, NY 10001, USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
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Details of Secondary Sponsor
|
| Name |
Address |
| Pfizer Limited |
The Capital, 1802/1901, Plot No. C-70, G Block, Bandra Kurla Complex, Bandra (East), Mumbai 400051, Maharashtra, India |
|
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Countries of Recruitment
|
Belgium
Bosnia and Herzegovina
Georgia
Hungary
India
Other
Serbia
Slovakia
Turkey
United Kingdom
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saumin Prakashbhai Shah |
Gujarat Hospital Gastro and Vascular Centre |
Basement, Gastro Unit,
Opposite Shree Ram Petrol Pump, Anand Mahal Road, Adajan, Surat, Gujarat – 395009, India
Surat
GUJARAT |
919408042224
dr.sauminpshah@gmail.com |
| Dr Kalpana Datta |
Medical College and Hospital |
Department of Pediatrics, Child Hub division, Third floor Faculty Room
88, College Street, Kolkata-700073, West Bengal, India
Kolkata
WEST BENGAL |
919836424144
drkalpanadatta@gmail.com |
| Dr Ganesh Laxmikant Kulkarni |
Oriion Citicare Hospital-Institutional Ethics Committee Oriion Citicare Super Speciality Hospital |
5-5-70, Opp Kalash Mangal Karyalaya new Osmanpura, Aurangabad 431005, Maharashtra
Aurangabad
MAHARASHTRA |
919823056067
drganeshkulkarni@hotmail.com |
| Dr Mukesh Kalla |
S R Kalla Memorial Gastro and General Hospital |
4th Floor, Clinical Research Department
78-79 Dhulehswar Garden Behind HSBC Bank
Sardar Patel Marg C-Scheme Jaipur-302001 Rajasthan India
Jaipur
RAJASTHAN |
9829050622
drmkalla@rediffmail.com |
| Dr B Ravi Shankar |
Yashoda Hospitals |
Department of Medical Gastroenterology, Room No: 9, 4th Floor
Behind Hari Hara Kala Bhavan, SP Road,
Secunderabad - 500003, Telangana, India
Hyderabad
TELANGANA |
919391075600
b_ravishankar@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for human Research, Medical College and Hospital |
Submittted/Under Review |
| Oriion Citicare Hospital Institutional Ethics Committee OCH-IEG Oriion Citicare Super Speciality Hospital, 5-5-70, opposite Kalash Mangal Karyalaya, New Osmanpura, Aurangabad - 431005 |
Approved |
| S.R.Kalla Memorial Ethical Committee for human Research S R Kalla Memorial Gastro and General Hospital |
Approved |
| Unity Hospital Ethics Committee, Gujarat Hospital – Gastro and Vascular Centre |
Approved |
| Yashoda Academy of medical education and Research, Yashoda Hospitals |
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: K208||Other esophagitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Active Comparator: Arm 2 Half Dose Pantoprazole and matching placebo Half Healing Dose of pantoprazole |
Drug: Half Dose Pantoprazole plus matching placebo Half healing dose of pantoprazole plus matching placebo Dosage form: Capsule Unit Dose Strength(s): 5 mg (7 kg to 15 kg) 10 mg (15 kg to 40 kg) 20 mg (≥40 kg) Dose levels: One per day |
| Intervention |
Active Comparator: Arm 1 Full Dose Pantoprazole and matching placebo
Full Healing Dose of pantoprazole |
Drug: Full dose Pantoprazole plus matching placebo
Full healing dose of pantoprazole plus matching placebo
Dosage: Capsules
Unit Dose Strength(s):
10 mg (7 kg to 15 kg)
20 mg (15 kg to 40 kg)
40 mg (≥40 kg)
Dose levels: One per day
|
| Comparator Agent |
Active Comparator: Arm 1 Full Dose Pantoprazole and matching placebo Full Healing Dose of pantoprazole |
Drug: Full dose Pantoprazole plus matching placebo Full healing dose of pantoprazole plus matching placebo Dosage: Capsules Unit Dose Strength(s): 10 mg (7 kg to 15 kg) 20 mg (15 kg to 40 kg) 40 mg (≥40 kg) Dose levels: One per day |
| Intervention |
Active Comparator: Arm 2 Half Dose Pantoprazole and matching placebo
Half Healing Dose of pantoprazole |
Drug: Half Dose Pantoprazole plus matching placebo
Half healing dose of pantoprazole plus matching placebo
Dosage form: Capsule
Unit Dose Strength(s):
5 mg (7 kg to 15 kg)
10 mg (15 kg to 40 kg)
20 mg (≥40 kg)
Dose levels: One per day |
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
(1) Participants must have a documented erosive lesion with an Los Angeles (LA) Grade of A to D prior to starting Proton Pump Inhibitor treatment
(2) Capable of giving signed informed consent or assent
(3) Willingness and ability of the participant or parent or legal guardian to complete the eDiary
(4) Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures, including the use of the eDiary.
(5) Male and female participants aged 1 to 17 years.
(6) Minimum body weight 7 kilogram and weight at least at the 5th percentile per the Center for Disease Control standard age and weight chart, for the participants age.
(7) To be considered a female of non childbearing potential, the participant must meet at least 1 of the following criteria
(8) Premenarchal-The investigator (or other appropriate staff) must discuss the participants premenarchal status with the participant and parent or legal guardian at office visits and during telephone contacts, as participants who achieve menarche during the study would no longer be considered female participants of non childbearing potential and must comply with the protocol requirements applicable to women of childbearing potential. |
|
| ExclusionCriteria |
| Details |
(1) Previous administration of an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
(2) Children that may be at high risk from procedural sedation should be carefully evaluated. Participants with a history of complications during prior procedural sedation
(3) History or presence of upper gastrointestinal anatomic or motor disorders
(4) Family history of malignant hyperthermia
(5) Known hypersensitivity to any Proton Pump Inhibitor, including pantoprazole or to any substituted benzimidazole or to any of the excipients.
(6) Any disorder requiring chronic (daily) use of warfarin, heparin, other anticoagulants, methotrexate, atazanavir or nelfinavir, clopidogrel, or potent inhibitors or inducers of CYP2C19 (eg, phenytoin, sulfamethoxazole, valproic acid, carbamazepine, and griseofulvin).
(7) Serum creatine kinase levels greater than 3 x upper limit of normal.
(8) Known history of human immunodeficiency virus or clinical manifestations of acquired immune deficiency syndrome.
(9) Active malignancy of any type, or history of a malignancy. Participants with a history of malignancies that have been surgically removed or eradicated by irradiation or chemotherapy and who have no evidence of recurrence for at least 5 years before Screening are acceptable.
(10) Diagnosed as having or has received treatment for esophageal, gastric, pyloric channel, or duodenal ulceration within 30 days before the Screening visit.
(11) Alanine aminotransferase or blood urea nitrogen greater than 2.0 upper limit of normal or estimated creatinine greater than 1.5 X upper limit of normal for age or any other laboratory abnormality considered by the Investigator to be clinically significant within 14 days before the Baseline Visit (Day 1).
(12) Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or study intervention administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
(13) Has, in the Investigators opinion, a serious chronic condition (eg, diabetes, epilepsy), which is either not stable or not well controlled and may interfere with the conduct of the study.
(14) Has any condition possibly affecting drug absorption (eg, gastrectomy).
(15) Prior or Concomitant Therapy:
(i) Frequent, repeated use of oral or parenteral glucocorticoids (eg, prednisone, prednisolone, dexamethasone). Steroid inhalers and topical steroids may be used.
(ii) Pregnant female participants; breastfeeding female participants.
(iii) Is unwilling or unable to comply with the Lifestyle Considerations section |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with endoscopically confirmed maintenance of healing of erosive esophagitis at Week 24, considering patients with excessive use of rescue medication as treatment failures |
Week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of Participants With Change From Baseline in Physical Examinations & Vital Signs |
Baseline up to 36 weeks |
| Incidence of Adverse Events (AEs) |
Baseline up to 36 weeks |
| Number of Participants With Change From Baseline in Laboratory Tests Results |
Baseline up to 36 weeks |
|
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Target Sample Size
|
Total Sample Size="126"
Sample Size from India="20"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
13/01/2022 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive esophagitis in pediatric participants aged 1 to 17 years with endoscopically-confirmed, healed erosive esophagitis. |