Pantoprazole Dose Comparison for Esophagitis

Not currently recruiting at 52 trial locations

Overseen By Pfizer CT.gov Call Center

Age: < 18

Sex: Any

Trial Phase: Phase 2

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 All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well two different doses of pantoprazole can maintain healing in children with erosive esophagitis, a condition where the esophagus becomes inflamed and damaged. Researchers compare a full dose and a half dose of pantoprazole to determine which is more effective and safe. Children aged 1 to 17 with previously healed erosive esophagitis, confirmed by endoscopy, may be suitable participants. The goal is to identify which dose works best and is better tolerated by young patients. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, contributing to important findings.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that pantoprazole is an FDA-approved medication for treating conditions with excessive stomach acid, such as erosive esophagitis. Studies have found it safe for children aged 1 to 16 years. Most children tolerate it well, though some may experience mild side effects like headaches or diarrhea. The treatment is generally considered safe due to its prior use in similar conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Pantoprazole is unique because it is being studied at both full and half healing doses to treat esophagitis, a condition that's typically managed with proton pump inhibitors (PPIs) like omeprazole or lansoprazole. Unlike the standard of care, which usually involves a fixed high dose, this study explores whether a lower dose of pantoprazole can be just as effective, potentially reducing side effects and cost. Researchers are excited about this treatment because it could offer a more personalized approach to dosing, allowing for effective management of esophagitis with fewer side effects.

What evidence suggests that this trial's treatments could be effective for esophagitis?

This trial will compare the effectiveness of different doses of pantoprazole for treating erosive esophagitis. Research has shown that pantoprazole effectively treats this condition, where the esophagus lining is damaged. One study found that a 40 mg dose led to quicker and better healing than lower doses, regardless of the condition's severity. Another study found that pantoprazole, at any dose, relieved acid reflux symptoms better than a placebo. Additionally, taking 40 mg of pantoprazole once a day proved effective and well-tolerated for symptom relief. This suggests that pantoprazole can help maintain healing in patients with erosive esophagitis. Participants in this trial will receive either a full healing dose or a half healing dose of pantoprazole to evaluate its effectiveness. ^{6 7 8 9 10}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Pantoprazole

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Published Research Related to This Trial

Esomeprazole 40 mg significantly maintains intragastric pH above 4 for a longer duration compared to other proton pump inhibitors (PPIs) like lansoprazole, omeprazole, pantoprazole, and rabeprazole, based on four randomized crossover studies involving patients with gastro-oesophageal reflux disorder (GERD).

The studies showed that esomeprazole not only achieved a higher percentage of time with pH greater than 4 but also resulted in a higher median pH and a greater proportion of patients maintaining pH above 4 for extended periods, indicating its superior efficacy in acid control.

NCBI (Pubmed)

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. Röhss, K., Lind, T., Wilder-Smith, C.[2022]

In a study of 15 pediatric patients aged 6 to 13 with reflux esophagitis, oral pantoprazole (20 mg daily) significantly reduced esophageal acid exposure time from 9.3% to 2.7% after 28 days, indicating effective gastric acid control.

All patients experienced at least partial relief from reflux symptoms, and 47% showed endoscopic healing of esophagitis, demonstrating that pantoprazole is both effective and safe for treating this condition in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral pantoprazole 20 mg given once daily for reflux esophagitis in children. Madrazo-de la Garza, A., Dibildox, M., Vargas, A., et al.[2019]

In a multicenter study comparing intravenous omeprazole and pantoprazole for treating acid-related diseases, pantoprazole was prescribed at significantly lower doses (40 mg/day) compared to omeprazole (80 mg/day), particularly for duodenal and gastric ulcers (p < 0.05).

Treatments using pantoprazole were found to be 54% less expensive than those using omeprazole, with cost savings of 65% for duodenal ulcers and 53% for gastric ulcers, suggesting that pantoprazole is a more cost-effective option for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cost-minimization study on the prescription of intravenous proton pump inhibitors: pantoprazole versus omeprazole]. García González, F., Soler Company, E., Hedo Aparicio, G.[2018]

In a study of 315 patients with reflux esophagitis, pantoprazole was found to be significantly more effective than ranitidine, achieving healing rates of 94% compared to 74% after eight weeks of treatment.

Both pantoprazole and ranitidine were well tolerated, with adverse event rates of less than 2% in each group, indicating that pantoprazole is a safe and effective option for treating reflux esophagitis.

NCBI (Pubmed)

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]. Gallo, S., Dibildox, M., Moguel, A., et al.[2022]

In a study of 217 patients with gastro-oesophageal reflux disease (GERD), pantoprazole provided faster relief from daytime symptoms (3.7 days) compared to esomeprazole (5.9 days), indicating its quicker efficacy.

Both pantoprazole and esomeprazole were found to be equally effective in reducing the overall load of GERD-related symptoms, suggesting that while pantoprazole acts faster, both medications are similarly effective in managing symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-daily pantoprazole 40 mg and esomeprazole 40 mg have equivalent overall efficacy in relieving GERD-related symptoms. Scholten, T., Gatz, G., Hole, U.[2019]

In a clinical trial involving 120 patients, pantoprazole (40 mg/day) demonstrated comparable healing rates to omeprazole (20 mg/day) for treating grade I and II GERD, with no significant differences in efficacy at both 4 and 8 weeks.

Both medications were well tolerated, with pantoprazole showing a favorable safety profile and being an effective short-term treatment option for reflux esophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole versus omeprazole in the treatment of reflux esophagitis. Vcev, A., Stimac, D., Vceva, A., et al.[2018]

In a study involving 307 patients with gastro-oesophageal reflux disease (GORD), pantoprazole (20 mg/d) provided significantly better symptom control compared to ranitidine (300 mg/d) over 12 months, with 77% of patients achieving complete symptom control versus 59% for ranitidine.

Pantoprazole demonstrated superior efficacy at multiple time points (4, 8, 6, and 12 months), indicating it is an effective alternative for both initial and long-term treatment of GORD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of pantoprazole versus ranitidine for the treatment of uninvestigated heartburn in primary care. Talley, NJ., Moore, MG., Sprogis, A., et al.[2020]

In a study involving 915 patients with gastroesophageal reflux disease (GERD), pantoprazole 40 mg provided significantly faster symptom relief compared to omeprazole 20 mg, with patients experiencing relief 2 days earlier.

After 6 weeks of treatment, both medications were well tolerated, and over 90% of patients in both groups reported being free from symptoms, indicating that pantoprazole is an effective option for GERD management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Financial restrictions in health care systems could affect treatment quality of GERD-patients]. Gillessen, A., Schöffel, L., Naumburger, A.[2018]

In a 28-day study involving 30 patients with GERD, including severe cases, pantoprazole (40 mg) was effective for 83.3% of patients, while 16.7% required an increased dose of 80 mg to achieve remission.

The study demonstrated both the efficacy and safety of pantoprazole in treating GERD, including its more severe forms, suggesting it can be a reliable treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Panum (pantoprazole) effectiveness in the treatment of patients with GERD]. Masharova, AA., Ianova, OB., Valitova, ÉR., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1936305/

Long-term management of gastroesophageal reflux ... On-demand treatment with pantoprazole 20 mg for 6 months was effective, compared with placebo, in maintaining control of the symptoms of heartburn, acid ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5894447/

Meta-analysis of the efficacy and safety of pantoprazole in the ... Therefore, this meta-analysis suggests that pantoprazole 40 mg once daily is an effective and well-tolerated choice for providing symptom relief of patients ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002927000020475

Oral pantoprazole for erosive esophagitis: a placebo ... The 40-mg pantoprazole dose produced greater rates of healing and earlier healing of esophagitis than either the 10- or 20-mg dose, regardless of severity.

4. link.springer.com link.springer.com/article/10.1007/s40801-025-00497-8

Assessment of Burden of Partial Response to Standard ... Pantoprazole 40 mg twice daily (BD) showed 49.1% improvement in heartburn and 50.9% in abdominal pain. Pantoprazole 80 mg DDR once daily ...

5. journals.lww.com journals.lww.com/ajg/abstract/2000/11000/oral_pantoprazole_for_erosive_esophagitis__a.9.aspx

Oral Pantoprazole for Erosive Esophagitis: A Placebo ... Pantoprazole, at any dose, was significantly more effective than placebo in relieving reflux symptoms. Patients on pantoprazole 40 mg experienced relief of ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/pantoprazole-oral-route/description/drg-20071434

Pantoprazole (oral route) - Side effects & dosage Pantoprazole is used to treat certain conditions in which there is too much acid in the stomach. It is used to treat erosive esophagitis or heartburn.

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/022020s011-020987s049lbl.pdf

PROTONIX (pantoprazole sodium) label - accessdata.fda.gov Safety of PROTONIX in the treatment of Erosive Esophagitis (EE) associated with GERD was evaluated in pediatric patients ages 1 year through 16 years in three ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499945/

Pantoprazole - StatPearls - NCBI Bookshelf Pantoprazole is a proton-pump inhibitor (PPI) approved by the FDA for the treatment and maintenance of erosive esophagitis associated with ...

9. go.drugbank.com go.drugbank.com/drugs/DB00213

Pantoprazole: Uses, Interactions, Mechanism of Action Safety and efficacy of pantoprazole injection as the initial treatment of patients having GERD with a history of erosive esophagitis have not been demonstrated ...

10. webmd.com webmd.com/drugs/2/drug-17633/pantoprazole-oral/details

Pantoprazole (Protonix) - Uses, Side Effects, and More Find patient medical information for Pantoprazole (Protonix) on WebMD including its uses, side effects and safety, interactions, pictures,