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.12345
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.46789
Is the drug Pantoprazole a promising treatment for nausea and vomiting?
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
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Treatment Details
Interventions
- Pantoprazole (Proton Pump Inhibitor)
Trial OverviewThe 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
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 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: PlaceboPlacebo Group1 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 United States, European Union, Canada, Japan, China, Switzerland for the following indications:
🇺🇸 Approved in United States as Protonix for:
- Erosive esophagitis
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
🇪🇺 Approved in European Union as Pantoprazole for:
- Erosive esophagitis
- Gastroesophageal reflux disease (GERD)
- Zollinger-Ellison syndrome
- Peptic ulcer disease
🇨🇦 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Naval Medical Center PortsmouthPortsmouth, VA
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Who Is Running the Clinical Trial?
United States Naval Medical Center, PortsmouthLead Sponsor
References
Basic aspects of selectivity of pantoprazole and its pharmacological actions. [2019]Pantoprazole sodium is a substituted benzimidazole derivative which controls acid secretion by inhibition of gastric H(+)/K(+)-ATPase. The prodrug pantoprazole accumulates in the acidic space of the parietal cell where it is converted to the pharmacologically active principle, a thiophilic cyclic sulfenamide. The pH-dependent activation profile, i.e., activation at pH 1 versus activation at pH 4-6, is more favorable for pantoprazole than for the other proton pump inhibitors (PPIs) currently available. In vitro, pantoprazole interferes less potently than omeprazole with biological targets not related to gastric acid secretion. The gastric target sites for the pantoprazole sulfenamide are the cysteines 813 and 822 of the catalytic subunit of the H(+)/K(+)-ATPase. In contrast to omeprazole, the two binding sites are located right at the proton channel. In rats, dogs and humans, pantoprazole produces marked and prolonged inhibition of both basal and stimulated acid secretion. Overall, its antisecretory potency is equal to that of omeprazole. Antiulcer activity has been demonstrated for pantoprazole in two rat models. As seen with H(2)-receptor antagonists and other PPIs, pantoprazole causes an increase in serum gastrin concentration which reflects the degree of gastric acid inhibition. Pantoprazole is mainly metabolized by CYP3A4 and 2C19, but displays a lower affinity for these phase I cytochrome P450 enzymes than omeprazole. In contrast to the latter, pantoprazole is further conjugated with sulfate by the hepatic phase II metabolism. These two differences may explain why pantoprazole does not interfere with the metabolism of any other drug thus far tested in humans.
A double-blind study of pantoprazole and omeprazole in the treatment of reflux oesophagitis: a multicentre trial. [2019]Pantoprazole is a new substituted benzimidazole which is a potent inhibitor of gastric acid secretion by its action upon H+,K(+)-ATPase.
Pantoprazole versus omeprazole in the treatment of acute gastric ulcers. [2019]Pantoprazole is a new substituted benzimidazole which is a potent inhibitor of gastric acid secretion by its action upon H+,K(+)-ATPase.
Comparison of pantoprazole and ranitidine in the treatment of acute duodenal ulcer. Pantoprazole-Duodenal Ulcer-Study Group. [2019]Pantoprazole is a new substituted benzimidazole that blocks the H+/K(+)-ATPase in the gastric mucosa and thus inhibits acid secretion.
Pantoprazole 20 mg is effective for relief of symptoms and healing of lesions in mild reflux oesophagitis. [2019]To investigate the efficacy of a low dose of pantoprazole, a gastric proton pump inhibitor, for the relief of symptoms and healing of lesions in mild gastro-oesophageal reflux disease (GERD), and to compare it with the efficacy of ranitidine.
Pantoprazole and omeprazole in the treatment of reflux oesophagitis: a European multicentre study. [2019]Pantoprazole is a new substituted benzimidazole which inhibits gastric H+,K(+)-ATPase.
Pantoprazole: a proton pump inhibitor with oral and intravenous formulations. [2018]Proton pump inhibitors (PPI) are a significant part of therapy for most acid-related diseases including gastroesophageal reflux disease, peptic ulcer disease and acute gastrointestinal bleeding. Pantoprazole is one of several available proton pump inhibitor agents and provides dose-dependent control of gastric acid secretion. Pantoprazole has indications in gastroesophageal reflux disease and peptic ulcer disease, along with indications as co-therapy in the eradication of Helicobacter pylori infection and in the control of the acid secretion associated with the Zollinger-Ellison syndrome, as well as in NSAID ulcer prevention. Pantoprazole is available in both oral and intravenous formulations. It is effective across all age groups, although only indicated in adults (and adolescents in Europe). It has been approved for use in over 100 countries and has been used for over 13 years. Pantoprazole has an excellent safety profile and a low potential for drug-drug interactions. While still widely prescribed, pantoprazole and the other branded proton pump inhibitors are under considerable market pressure from the less expensive but similarly effective generic and over-the-counter formulations of omeprazole.
[Evaluation of unexpected and toxic effects of omeprazole (Mopral) reported to the regional centers of pharmacovigilance during the first 22 postmarketing months]. [2013]Omeprazole has been marketed in France since 1989, for the healing of peptic ulcers, erosive reflux esophagitis and the Zollinger Ellison syndrome. It is a proton pump inhibitor which inhibits the acid secretion in the stomach. In the majority of the clinical trials, omeprazole has been found to be well tolerated: headache, dizziness, skin rash, constipation have just been noted. Since September 1989, 143 adverse reactions have been reported to pharmacovigilance centres and Astra France: 37 neurological and psychiatric side effects, especially confusion in patients with hepatic diseases and/or advanced age; 35 cutaneous reactions, generally rash and urticaria; 22 hematological effects: leucopenia and agranulocytosis have been reported but the relation with omeprazole is very uncertain; 10 gastrointestinal effects, generally diarrhoea, nausea, vomiting and abdominal pain; 8 hepatic disorders, especially moderate elevation of aminotransferases. This study confirms the safety of this drug, during short treatment; the frequency of notified adverse effects is about 1/12 200 treatments of 4 weeks. The ministry of health, has decided, in november 1991, to inform the prescribers of this potential toxicity of omeprazole, particularly, of the risk of confusion, hepatotoxicity and leucopenia.
Liver hepatotoxicity associated with pantoprazole: a rare case report. [2021]Hepatotoxicity may occasionally develop over the course of treatment with proton pump inhibitors (PPIs). Although skin reactions, interstitial nephritis, pancytopenia, anaphylaxis, and generalized edema have been reported to be associated with PPIs, hepatotoxicity associated with oral pantoprazole is very rare. In this report, we present a case of hepatotoxicity in a 35-year-old man who received pantoprazole (40 mg/day) for acute gastritis. One week after discontinuation of pantoprazole, his liver function began to improve, and the patient gradually fully recovered. Although this toxicity occurs only infrequently, pantoprazole should be considered as a rare hepatotoxic agent in the literature.
[Treatment of tumor therapy-induced nausea and vomiting]. [2022]Even today, nausea and vomiting are two of the most distressing adverse effects associated with tumor therapy. The authors give an overview of the mechanism and the trigger factors (emetogenic potential of the chemotherapies, the patient risk factors, and the used antiemetic drugs) of nausea and vomiting. A short summary will describe the antiemetic drugs focusing on metoclopramide, steroid and the currently widely used setron therapy which is effective only during the acute phase of chemotherapy-induced nausea and vomiting (CINV). In the treatment of CINV the latest improvement was the introduction of the neurokinin (NK1) receptor antagonist class. Currently the only available agent is aprepitant which is indicated to treat CINV in case of highly and moderately emetogenic chemotherapies. The pivotal phase III trials defined that aprepitant is the first drug that is able to protect against the delayed phase of CINV plus can improve the antiemetic therapy during the acute phase. Currently aprepitant is reimbursed in Hungary only after the failure of setron therapy in case of high dose (>50 mg/m2) cisplatin protocols. The authors give a recommendation how to treat CINV based on the latest international antiemetic guidelines.The mechanism and the trigger factors of radiotherapy-induced nausea and vomiting (RINV) are different from CINV. For treatment of RINV metoclopramide (due to reimbursement regulation) and ondansetron can be used. In case of radio-chemotherapy the antiemetic treatment should follow the CINV guidelines.
[Croatian guideliness for prevention of chemotherapy induced nausea and vomiting]. [2009]Approximately 70-80% of all cancer patients receiving chemotherapy experience nausea and/or vomiting. Nausea and vomiting are important side effects of cancer treatment, which can significantly affect a patient's quality of life, leading to poor compliance with further chemotherapy treatment. The main principle of emesis control is prevention. Currently available antiemetic agents corticosteroids, 5-hydroxytriptamine receptor antagonists, and neurokinin-1 antagonists, are used alone or in combination. Antiemetic regimen should be chosen based on the emetogenic potential of the chemotherapy regimen, previous experience with antiemetics, and patient-specific risk factors. Newer agents, including second generation 5-HT3 receptor antagonist palonosetron and the NK-1 antagonist aprepitant, offer additional clinical benefit in highly and moderately emetogenic therapy, especially in delayed nausea and vomiting. The aim of this Guidelines is to achieve same standards of care in the treatment of nausea and vomiting across Croatia that are applicable in our environment--only available drugs are included in the Guidelines.
State of the Art Antiemetic Therapy for Cancer Patients. [2018]Nausea and vomiting are common in cancer patients. The most common cause of nausea and vomiting is the administration of cytotoxic chemotherapy. Apart from chemotherapy-induced nausea and vomiting (CINV), biological agents may also cause these symptoms. In this review, discussion will be focused on management of nausea and vomiting due to antineoplastic therapies. The cornerstone of effective management of nausea and vomiting secondary to these antineoplastic drugs is the prevention with the use of appropriate guideline-directed combination antiemetic regimen. Type 3 serotonin receptor antagonists (5HT3RAs), neurokinin-1 receptor antagonists (NK1RAs), and dexamethasone are the backbone antiemetic drugs. In recent years, newer drugs and preparations have been introduced for clinical use and include second-generation 5HT3RA, palonosetron; granisetron transdermal patch; the recently introduced NK1RA rolapitant; and the novel oral combined drug NEPA (netupitant plus palonosetron); and last but not least, the atypical antipsychotic olanzapine.
Optimizing emetic control in children receiving antineoplastic therapy: beyond the guidelines. [2021]Existing guidelines for the prevention of antineoplastic chemotherapy-induced nausea and vomiting (CINV) in children are constrained by the lack of robust evidence. Current guidelines recommend the use of a serotonin 5-HT(3) receptor antagonist plus a corticosteroid to prevent acute CINV. Consequently, antiemetic agents that are recommended for use in adult cancer patients do not appear in the current pediatric guidelines. In addition, there is no information to guide the selection of alternative antiemetic agents for children who either cannot receive the recommended agents or who do not respond adequately to the treatment. Possible barriers to adherence to the pediatric antiemetic selection guidelines that are currently available are discussed, and published pediatric experience with antiemetic agents recommended in the current adult antiemetic selection guidelines (dolasetron, tropisetron, palonosetron, aprepitant) is summarized in this review. The use of novel and emerging antiemetic therapeutic interventions {metopimazine, diphenhydramine (Benadryl)-lorazepam (Avitan)-dexamethasone (Decadron) [BAD], nabilone, acupuncture, midazolam, olanzapine, mirtazapine, gabapentin, droperidol} in children are explored.
A survey of antiemetic use in children with cancer. [2015]Pediatric oncologists within Pediatric Oncology Group institutions were surveyed to determine current antiemetic practices for children receiving chemotherapy and the basis for those practices. A mean severity rating for associated nausea and vomiting was calculated and used to rank 31 chemotherapeutic agents commonly used in the treatment of childhood cancer. Antiemetics were used 17%, 79%, and 98% of the time for chemotherapeutic agents with mild, moderate, or severe associated nausea and vomiting, respectively. A median of one, two, and three antiemetics were used for mild, moderate, and severe agents, respectively. Antihistamines and phenothiazines were the drugs most commonly used for agents causing mild or moderate nausea and vomiting, and metoclopramide hydrochloride/antihistamines with lorazepam and/or corticosteroids were used most often for chemotherapeutic agents causing severe nausea and vomiting. Most oncologists based their choice of antiemetics on personal experience. Current literature addressing the treatment of nausea and vomiting in children receiving chemotherapy, as reviewed here, does not always support the present clinical practices.