Pantoprazole for Nausea and Vomiting

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: United States Naval Medical Center, Portsmouth

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to see if pantoprazole (a proton pump inhibitor used for acid reflux/heart burn) can reduce nausea and vomiting after gynecologic surgery in women between the ages of 18 and 79. Researchers will compare a placebo to the active medication. Participants will be asked to take three pills around their surgery, two taken before and one taken the night after.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are using H2 receptor blockers, proton pump inhibitors, or other GERD-specific therapies, you cannot participate in the trial.

What data supports the idea that Pantoprazole for Nausea and Vomiting is an effective drug?

The available research shows that Pantoprazole is effective in treating conditions related to stomach acid, like reflux oesophagitis and gastric ulcers, by reducing acid production. However, there is no specific data provided about its effectiveness for nausea and vomiting. Pantoprazole is compared to other drugs like ranitidine and omeprazole for acid-related conditions, but not directly for nausea and vomiting. Therefore, while it is effective for acid-related issues, there is no direct evidence here supporting its use for nausea and vomiting. ^{1 2 3 4 5}

What safety data exists for pantoprazole?

Pantoprazole is a proton pump inhibitor used to treat acid-related diseases. It has been approved in over 100 countries and used for over 13 years, with an excellent safety profile and low potential for drug-drug interactions. Rare cases of hepatotoxicity have been reported, but it is generally well-tolerated. Common side effects of similar drugs include headache, dizziness, skin rash, and gastrointestinal issues. Pantoprazole is available in oral and intravenous forms and is effective across all age groups, though primarily indicated for adults. ^{4 6 7 8 9}

Is the drug Pantoprazole a promising treatment for nausea and vomiting?

The research articles focus on other drugs like serotonin receptor antagonists and neurokinin-1 receptor antagonists for treating nausea and vomiting, especially in cancer patients. Pantoprazole is not mentioned as a promising treatment for these symptoms in the provided studies. ^{10 11 12 13 14}

Research Team

Eligibility Criteria

This trial is for women aged 18-79 undergoing gynecologic surgery, aiming to see if pantoprazole can prevent postoperative nausea and vomiting. Specific eligibility criteria are not provided.

Inclusion Criteria

I am scheduled for gynecological surgery under general anesthesia.

Exclusion Criteria

I am receiving treatment for a gastrointestinal condition.

I have had gastrointestinal surgery, but only for diagnosis, appendix removal, or gallbladder removal.

Lactose intolerance

Treatment Details

Interventions

• Pantoprazole (Proton Pump Inhibitor)

Trial Overview The study tests whether pantoprazole, an acid reflux medication, is better than a placebo at preventing nausea and vomiting after surgery. Participants will take three pills around their operation time.

Participant Groups

Group I: Active Active Control 1 Intervention

This arm receives the pantoprazole 40mg tablet. This medication is taken the night before, 2 hours before surgery, and the night after surgery.

Group II: Placebo Placebo Group 1 Intervention

This arm receives the placebo drug. This medication is taken the night before, 2 hours before surgery, and the night after surgery.

Pantoprazole is already approved in Canada, Japan, China, Switzerland for the following indications:

Approved in Canada as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in Japan as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in China as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Approved in Switzerland as Pantoprazole for:

• Erosive esophagitis
• Gastroesophageal reflux disease (GERD)
• Zollinger-Ellison syndrome

Who Is Running the Clinical Trial?

United States Naval Medical Center, Portsmouth

Lead Sponsor

Trials

35

Recruited

4,900+

Findings from Research

Pantoprazole effectively inhibits gastric acid secretion by targeting the H(+)/K(+)-ATPase enzyme, with a favorable activation profile at lower pH levels compared to other proton pump inhibitors, making it a potent option for acid-related disorders.

Unlike omeprazole, pantoprazole has a lower potential for drug interactions due to its unique metabolic pathway, which may enhance its safety profile in patients taking multiple medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Basic aspects of selectivity of pantoprazole and its pharmacological actions. Beil, W., Sewing, KF., Kromer, W.[2019]

In a study of 286 patients with reflux oesophagitis, both pantoprazole (40 mg) and omeprazole (20 mg) demonstrated similar healing rates after 4 weeks (74% vs. 78%) and 8 weeks (90% vs. 94%), indicating comparable efficacy in treating the condition.

Both medications were well tolerated by patients, suggesting that they are safe options for treating mild to moderate reflux oesophagitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A double-blind study of pantoprazole and omeprazole in the treatment of reflux oesophagitis: a multicentre trial. Mössner, J., Hölscher, AH., Herz, R., et al.[2019]

In a study of 219 patients with benign gastric ulcers, pantoprazole (40 mg) demonstrated a higher healing rate after 4 weeks (88%) compared to omeprazole (77%), indicating its efficacy as a treatment.

Both pantoprazole and omeprazole were found to be equally safe, with only 10% of patients in each group reporting adverse events, suggesting that pantoprazole is a well-tolerated option for treating gastric ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole versus omeprazole in the treatment of acute gastric ulcers. Witzel, L., Gütz, H., Hüttemann, W., et al.[2019]

In a study involving 202 outpatients, pantoprazole (40 mg) demonstrated a significantly higher healing rate for acute duodenal ulcers compared to ranitidine (300 mg), with 81% healing after 2 weeks versus 53% for ranitidine (P < 0.001).

After 4 weeks, pantoprazole continued to show superior efficacy with a healing rate of 97% compared to 83% for ranitidine (P < 0.01), and both treatments were well tolerated by patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of pantoprazole and ranitidine in the treatment of acute duodenal ulcer. Pantoprazole-Duodenal Ulcer-Study Group. Judmaier, G., Koelz, HR.[2019]

In a study of 209 patients with mild gastro-oesophageal reflux disease (GERD), low-dose pantoprazole (20 mg) provided significantly faster relief from symptoms compared to ranitidine (300 mg), with 69% of patients reporting complete relief after 2 weeks versus 48% for ranitidine.

Pantoprazole also demonstrated superior healing of GERD lesions, with 80% of patients showing healing after 4 weeks compared to 64% in the ranitidine group, indicating its greater efficacy in treating mild GERD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. Dettmer, A., Vogt, R., Sielaff, F., et al.[2019]

In a double-blind study involving 208 patients, pantoprazole (40 mg daily) was found to be as effective as omeprazole (20 mg daily) in healing reflux esophagitis after 4 and 8 weeks, with healing rates of 94.2% for pantoprazole and 91.4% for omeprazole.

Both medications provided rapid relief from symptoms like heartburn and pain on swallowing, and were well tolerated, with very few adverse events leading to treatment withdrawal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole and omeprazole in the treatment of reflux oesophagitis: a European multicentre study. Corinaldesi, R., Valentini, M., Belaïche, J., et al.[2019]

Pantoprazole is an effective proton pump inhibitor used to treat various acid-related conditions, including gastroesophageal reflux disease and peptic ulcer disease, and has been safely used for over 13 years in more than 100 countries.

It has a strong safety profile with low risk for drug interactions, making it suitable for patients across all age groups, although it is officially indicated only for adults and adolescents in Europe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pantoprazole: a proton pump inhibitor with oral and intravenous formulations. Devault, KR.[2018]

Aprepitant, a neurokinin (NK1) receptor antagonist, is the first drug shown to effectively prevent both the acute and delayed phases of chemotherapy-induced nausea and vomiting (CINV), marking a significant advancement in antiemetic therapy.

Current guidelines recommend using aprepitant for patients undergoing highly and moderately emetogenic chemotherapy, although it is only reimbursed in Hungary after other antiemetic treatments have failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treatment of tumor therapy-induced nausea and vomiting]. Pikó, B., Bassam, A.[2022]

70-80% of cancer patients undergoing chemotherapy experience nausea and vomiting, which can severely impact their quality of life and adherence to treatment.

Newer antiemetic agents like palonosetron and aprepitant provide additional benefits in managing delayed nausea and vomiting, particularly in patients receiving highly and moderately emetogenic chemotherapy regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Croatian guideliness for prevention of chemotherapy induced nausea and vomiting]. Tomek, R., Vrdoljak, E., Vrbanec, D., et al.[2009]

Effective management of nausea and vomiting in cancer patients, particularly from chemotherapy, relies on a guideline-directed combination of antiemetic medications, including 5HT3 receptor antagonists, NK1 receptor antagonists, and dexamethasone.

Recent advancements in antiemetic therapy include new drugs like palonosetron, rolapitant, and the combined drug NEPA, which enhance the prevention of chemotherapy-induced nausea and vomiting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

State of the Art Antiemetic Therapy for Cancer Patients. Lau, TK., Yip, CH., Yeo, W.[2018]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Basic aspects of selectivity of pantoprazole and its pharmacological actions. [2019]

2. England pubmed.ncbi.nlm.nih.gov

A double-blind study of pantoprazole and omeprazole in the treatment of reflux oesophagitis: a multicentre trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Pantoprazole versus omeprazole in the treatment of acute gastric ulcers. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Comparison of pantoprazole and ranitidine in the treatment of acute duodenal ulcer. Pantoprazole-Duodenal Ulcer-Study Group. [2019]

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

Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Pantoprazole and omeprazole in the treatment of reflux oesophagitis: a European multicentre study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Pantoprazole: a proton pump inhibitor with oral and intravenous formulations. [2018]

8. France pubmed.ncbi.nlm.nih.gov

[Evaluation of unexpected and toxic effects of omeprazole (Mopral) reported to the regional centers of pharmacovigilance during the first 22 postmarketing months]. [2013]

9. Austria pubmed.ncbi.nlm.nih.gov

Liver hepatotoxicity associated with pantoprazole: a rare case report. [2021]

10. Hungary pubmed.ncbi.nlm.nih.gov

[Treatment of tumor therapy-induced nausea and vomiting]. [2022]

11. Croatia pubmed.ncbi.nlm.nih.gov

[Croatian guideliness for prevention of chemotherapy induced nausea and vomiting]. [2009]

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

State of the Art Antiemetic Therapy for Cancer Patients. [2018]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Optimizing emetic control in children receiving antineoplastic therapy: beyond the guidelines. [2021]

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

A survey of antiemetic use in children with cancer. [2015]