Pantoprazole Dose Comparison for Esophagitis

Recruiting at 49 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

110 Participants Needed

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}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

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

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

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

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

Findings from Research

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]

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 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 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 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 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 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]

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 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]

References

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

[Panum (pantoprazole) effectiveness in the treatment of patients with GERD]. [2018]

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

Pantoprazole versus omeprazole in the treatment of reflux esophagitis. [2018]

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]

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

Randomised controlled trial of pantoprazole versus ranitidine for the treatment of uninvestigated heartburn in primary care. [2020]

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]

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]

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

[Financial restrictions in health care systems could affect treatment quality of GERD-patients]. [2018]

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]

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

[Cost-minimization study on the prescription of intravenous proton pump inhibitors: pantoprazole versus omeprazole]. [2018]