Pantoprazole Dose Comparison for Esophagitis

Recruiting in Palo Alto (17 mi)

+49 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Pfizer

Must be taking: Proton pump inhibitors

Must not be taking: Anticoagulants, Methotrexate, Atazanavir, others

Disqualifiers: HIV, Active malignancy, Upper GI disorders, others

No Placebo Group

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants do not use certain medications like warfarin, heparin, methotrexate, and some others. If you are on these medications, you may need to stop them to participate in the trial.

What data supports the effectiveness of the drug pantoprazole for treating esophagitis?

Research shows that pantoprazole is effective in treating gastroesophageal reflux disease (GERD), including severe forms like reflux esophagitis. In studies, pantoprazole helped most patients achieve symptom relief and healing, with similar effectiveness to other treatments like omeprazole and esomeprazole. ^{1 2 3 4 5}

How does pantoprazole differ from other drugs for esophagitis?

Pantoprazole is unique because it can be adjusted in dosage based on the severity of esophagitis, with some patients requiring a higher dose for effective treatment. It is also available in both oral and intravenous forms, offering flexibility in administration compared to some other similar drugs. ^{1 6 7 8 9}

Eligibility Criteria

Children aged 1-17 with healed erosive esophagitis are eligible for this trial. They must weigh at least 7 kg and be in the CDC's weight percentile for their age. Participants need to consent, use an eDiary, and follow study procedures. Exclusions include hypersensitivity to Proton Pump Inhibitors, certain gastrointestinal disorders, psychiatric conditions, chronic medication use that interferes with the study drug, or significant lab abnormalities.

Inclusion Criteria

I am between 1 and 17 years old.

I am able to understand and sign the consent form.

I have a documented erosive lesion graded A to D before starting acid reflux treatment.

Exclusion Criteria

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)

I have HIV/AIDS.

Children that may be at high risk from procedural sedation should be carefully evaluated. Participants with a history of complications during prior procedural sedation

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a full healing dose or half healing dose of pantoprazole for maintenance of healing of erosive esophagitis

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Pantoprazole (Proton Pump Inhibitor)

Trial Overview The trial is testing two doses of oral pantoprazole (full healing dose and half healing dose) based on weight to maintain healing of erosive esophagitis in children. The effectiveness and safety of these doses will be compared over time.

Participant Groups

Group I: Arm 1 Full Dose Pantoprazole and matching placebo Active Control 1 Intervention

Full Healing Dose of pantoprazole

Group II: Arm 2 Half Dose Pantoprazole and matching placebo Active Control 1 Intervention

Half Healing Dose of pantoprazole

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Baptist/Wolfson's Children's Hospital Jacksonville, FL

Nemours Children's Specialty Care Jacksonville, FL

Children's Health / Children's Medical Center Dallas, TX

Children's Healthcare of Atlanta-Egleston Atlanta, GA

More Trial Locations

Who Is Running the Clinical Trial?

Pfizer Lead Sponsor

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Panum (pantoprazole) effectiveness in the treatment of patients with GERD]. [2018] There are demonstrated results of a prospective comparative study on clinical efficacy and tolerability of Panum (INN: pantoprazole) under the sponsorship of"Unique Pharmaceutical Laboratories (India)". Were evaluated the results of a 28-day course of treatment of 30 patients with GERD, including those with severe reflux esophagitis (erosive and ulcerative), who received 40 mg of pantoprazole as monotherapy. Was found an algorithm with an intermediate control efficacy to individualizing the approach to therapy. As a result 16,7% of patients with severe reflux esophagitis required increasing the dose of pantoprazole to 80 mg/day in two divided doses, and the rest (83,3%) patients to achieve clinical and endoscopic remission of GERD was sufficient single dose of 40 mg of the drug. The results of this study indicated the efficacy and safety of the Panum drug in the treatment of GERD, including its complicated forms.

2. Croatia pubmed.ncbi.nlm.nih.gov

Pantoprazole versus omeprazole in the treatment of reflux esophagitis. [2018] Pantoprazole is a new proton pump inhibitor with a potent antisecretory activity, well defined pharmacokinetics and safety profile. The aim of this single blind, randomized clinical trial was to compare the efficacy of pantoprazole (PAN) 40 mg/day and omeprazole (OME) 20 mg/day in patients with grade I and II GERD (Savary-Miller classification). A total of 120 patients were included (PAN = 60 and OME = 60). In the per protocol/analysis, healing rates at 4 weeks were 76.3% PAN and 71.2% OME (ns), and at 8 weeks 94.7% PAN and 92.9% OME (ns). In the intention to treat analysis, healing rates at 4 weeks were 75% PAN and 70% OME (ns), and at 8 weeks 90% PAN and 86.6% OME (ns). Both pantoprazole and omeprazole were well tolerated with no serious drug related adverse events. Pantoprazole 40 mg/day was found to be safe and effective therapy comparable to omeprazole 20 mg/day in the short-term treatment for reflux esophagitis (grade I and II).

3. Mexico pubmed.ncbi.nlm.nih.gov

[Clinical superiority of pantoprazole over ranitidine in the treatment of reflux esophagitis grade II and III. A prospective, double-blind, double-placebo study. Mexican clinical experience. Mexican Pantoprazole Study Group]. [2022] To compare and contrast the efficacy and tolerability of a proton pump inhibitor, pantoprazole, to that of an H2 antagonist, ranitidine, in the treatment of patients with mild to severe reflux esophagitis.

4. Australia pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of pantoprazole versus ranitidine for the treatment of uninvestigated heartburn in primary care. [2020] To investigate whether pantoprazole (20 mg/d) produces significantly greater symptom control than ranitidine (300 mg/d) in patients with gastro-oesophageal reflux disease (GORD).

5. England pubmed.ncbi.nlm.nih.gov

Once-daily pantoprazole 40 mg and esomeprazole 40 mg have equivalent overall efficacy in relieving GERD-related symptoms. [2019] To compare the efficacy of pantoprazole and esomeprazole for the treatment of gastro-oesophageal reflux disease- (GERD-) related symptoms.

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral pantoprazole 20 mg given once daily for reflux esophagitis in children. [2019] To investigate the efficacy and safety of oral pantoprazole, 20 mg (0.5 to 1.0 mg/kg/day) once daily for 28 days, in pediatric patients with reflux esophagitis.

7. Germany pubmed.ncbi.nlm.nih.gov

[Financial restrictions in health care systems could affect treatment quality of GERD-patients]. [2018] To directly compare the efficacy and safety of pantoprazole 40 mg VS. omeprazole 20 mg in patients with gastroesophageal reflux disease (GERD).

8. Germany pubmed.ncbi.nlm.nih.gov

Esomeprazole 40 mg provides more effective intragastric acid control than lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg and rabeprazole 20 mg in patients with gastro-oesophageal reflux symptoms. [2022] To compare the effect of esomeprazole 40 mg with lansoprazole 30 mg, omeprazole 20 mg, pantoprazole 40 mg and rabeprazole 20 mg on intragastric pH during single and repeated dosing in four separate studies in patients with symptoms of gastro-oesophageal reflux disorder (GERD).

9. Spain pubmed.ncbi.nlm.nih.gov

[Cost-minimization study on the prescription of intravenous proton pump inhibitors: pantoprazole versus omeprazole]. [2018] To compare and quantify intravenous omeprazole versus intravenous pantoprazole prescription habits in common acid-related diseases such as gastro-esophageal reflux disease, duodenal ulcer, and gastric ulcer.