SUMMARY
PROTONIX® I.V.
(pantoprazole sodium)
for Injection
The active ingredient in PROTONIX® I.V. (pantoprazole sodium) for Injection is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1H-benzimidazole, a compound that inhibits gastric acid secretion.
Treatment of Gastroesophageal Reflux Disease Associated With a History of Erosive Esophagitis
PROTONIX I.V. for Injection is indicated for short-term treatment (7 to 10 days) of patients with gastroesophageal reflux disease (GERD) and a history of erosive esophagitis.
Pathological Hypersecretion Associated with Zollinger-Ellison Syndrome
PROTONIX I.V. for Injection is indicated for the treatment of pathological hypersecretory conditions associated with Zollinger-Ellison Syndrome or other neoplastic conditions.
|
NEWS HIGHLIGHTS
Published Studies Related to Protonix Injection (Pantoprazole)
Efficacy of S-pantoprazole 20 mg compared with pantoprazole 40 mg in the
treatment of reflux esophagitis: a randomized, double-blind comparative trial. [2012]
esophagitis... CONCLUSION: The efficacy and safety of 20 mg S-pantoprazole were comparable to
Effect of gastric acid suppression with pantoprazole on the efficacy of sevelamer
hydrochloride as a phosphate binder in haemodialysis patients: a pilot study. [2012]
Sevelamer hydrochloride (HCL) is thought to require an appropriately acidic
environment in order to bind gastrointestinal phosphate. Changes in gastric
acidity with acid suppressants may therefore alter the efficacy of sevelamer HCL... Although our study did not find a significant drug
interaction, given the high prevalence of acid suppressant use in dialysis
patients, physicians should be aware of the potential influence of acid
suppression on the efficacy of phosphate binders and regularly assess the
clinical need for acid suppression therapy.
Randomized, open-label, multicentre pharmacokinetic studies of two dose levels of pantoprazole granules in infants and children aged 1 month through <6 years with gastro-oesophageal reflux disease. [2011.08.01]
BACKGROUND AND OBJECTIVE: The primary objective of this study was to characterize the pharmacokinetic profile of pantoprazole delayed-release granules in infants and children aged 1 month to <6 years with gastro-oesophageal reflux disease (GORD). The studies described in this manuscript were conducted to fulfil the requirements of the paediatric written request for pantoprazole by the US FDA... CONCLUSIONS: Exposure increased with increasing doses of pantoprazole granules, even though wide interindividual variability was observed. Compared with that in adults receiving pantoprazole 40 mg, exposure obtained with the 1.2 mg/kg dose was similar in study 1 and slightly lower in study 2. Pantoprazole was generally well tolerated in infants and children aged 1 month through <6 years with GORD. Trial registration numbers (ClinicalTrials.gov): NCT00259012 (study 1) and NCT00141817 (study 2).
Pharmacodynamic evaluation of pantoprazole therapy on clopidogrel effects: results of a prospective, randomized, crossover study. [2011.06]
CONCLUSIONS: Pantoprazole therapy used at high doses is not associated with modulation of the pharmacodynamic effects of clopidogrel, irrespective of timing of drug administration. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01170533.
A multicenter, randomized, open-label, pharmacokinetics and safety study of pantoprazole tablets in children and adolescents aged 6 through 16 years with gastroesophageal reflux disease. [2011.06]
Children with gastroesophageal reflux disease (GERD) may benefit from gastric acid suppression with proton pump inhibitors such as pantoprazole. Effective treatment with pantoprazole requires correct dosing and understanding of the drug's kinetic profile in children... In children aged 6 to 16 years with GERD, currently available pantoprazole delayed-release tablets can be used to provide systemic exposure similar to that in adults.
Clinical Trials Related to Protonix Injection (Pantoprazole)
Effect of Digene Total Buffered Pantoprazole)on 24 Hour Gastric pH in Patients Suffering From Acid Peptic Disorder After Single and Repeated Dosing [Not yet recruiting]
Effect of Pantoprazole on the Symptoms of Acid Reflux Disease in Adult Patients (BY1023/M3-341) [Active, not recruiting]
The aim of the present study is to identify factors (such as symptom patterns and symptom
scores) that influence the response to treatment with pantoprazole using different evaluation
methods (e. g. ReQuestâ„¢ questionnaire, patient and investigator assessment). Pantoprazole will
be administered once daily in the morning at one dose level. The study duration consists of a
treatment period of 8 weeks. The study will provide further data on safety and tolerability
of pantoprazole.
Efficacy of Pantoprazole in Patients Older Than 18 Years Who Have Symptoms of Non-Erosive Reflux or Gastroesophageal Reflux Disease (BY1023/DE-004) [Completed]
The aim of the study is to evaluate the effect of pantoprazole on fast symptom reduction in
hospitalized patients with NERD (non-erosive reflux disease) or GERD (gastroesophageal reflux
disease, Los Angeles [LA] Grade A-D). During the study, the patients will complete a
patient-orientated, self-assessed reflux questionnaire (ReQuestâ„¢). The study duration
consists of a treatment period of 7 days ± 3 days. Pantoprazole (tablet) will be administered
once daily in the morning to patients with NERD or GERD at one dose level for each
indication. The study will provide further data on the safety and tolerability of
pantoprazole.
Intravenous (IV) Pantoprazole for Gastroesophageal Reflux Disease (GERD) in Neonates and Infants [Recruiting]
The purpose of this study is to determine how the body uses and eliminates pantoprazole, a
drug used to treat GERD. This is a pharmacokinetic (PK) study. PK is a measure of how much
drug is in the blood and how long it takes to leave the body. It is hypothesized that
younger infants will need a lower dose than older children to achieve the same PK
measurement.
The results of this study will be used to determine the best dose of the drug to use in each
age group. Pantoprazole is a drug used to decrease acid production. The use of pantoprazole
has not been approved for use in children. Pantoprazole is approved for use of acid-related
and stomach disorders in adults.
Study Evaluating Pantoprazole With Doxorubicin for Advanced Cancer Patients With Extension Cohort of Patients With Solid Tumours [Recruiting]
This is a single-centre, open label, dose finding, phase I study to determine the
recommended phase II dose (RP2D) for the combination of doxorubicin and pantoprazole in
patients with advanced tumours and no standard treatment options. A minimum of 3 patients
will be enrolled per dose level and intra-patient dose escalation is not permitted. Once the
RP2D has been identified, six additional patients with metastatic solid tumours will be
treated at the RP2D to confirm its tolerability.
|
