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Generated: December 14, 2018

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CLINICAL TRIALS PROFILE FOR NIZATIDINE

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Clinical Trials for Nizatidine

Trial ID Title Status Sponsor Phase Summary
NCT00373334 Safety and Efficacy Study of Axid Use in Infants Suffering From Gastroesophageal Reflux Disease (GERD) Completed Braintree Laboratories Phase 3 The objective of this study is to evaluate the efficacy, acceptability, and safety of Axid Oral Solution versus placebo in the treatment of gastroesophageal reflux disease (GERD) in infants age 30 days up to 1 year.
NCT00486005 Weight Gain Management in Patients With Schizophrenia Completed Eli Lilly and Company Phase 4 Evaluate the efficacy of nizatidine in reducing/limiting weight gain in patients with schizophrenia who have been under treatment with olanzapine for at least two months and evaluate the treatment effects on the Eating Inventory, BPRS, number of treatment, emergent adverse events, changes in vital signs, laboratory results and extrapyramidal effects.
NCT01161927 Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 The purpose of this study is to compare experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions.
NCT01161940 Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited under fasting conditions
NCT01409395 Drug-Drug Interaction Study With Metformin and Nizatidine Completed National Institute of General Medical Sciences (NIGMS) Phase 1 This study will address the following question: Does nizatidine affect the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that nizatidine may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of metformin. The investigators hypothesize that the co-administration of metformin and nizatidine will reduce the renal clearance (CLR) of metformin leading to increased plasma concentrations and potential risk for toxicities. Knowledge of the pharmacokinetic interaction profile of metformin with organic transporter inhibitors, such as nizatidine, is important to help develop safer more effective drug therapy with reduced side effects.
NCT01409395 Drug-Drug Interaction Study With Metformin and Nizatidine Completed University of California, San Francisco Phase 1 This study will address the following question: Does nizatidine affect the pharmacokinetics of metformin in healthy volunteers? Recent studies in the Giacomini laboratory have indicated that nizatidine may block metformin elimination from the kidney by inhibiting organic cation transporter efflux of metformin. The investigators hypothesize that the co-administration of metformin and nizatidine will reduce the renal clearance (CLR) of metformin leading to increased plasma concentrations and potential risk for toxicities. Knowledge of the pharmacokinetic interaction profile of metformin with organic transporter inhibitors, such as nizatidine, is important to help develop safer more effective drug therapy with reduced side effects.
NCT02232308 Modulation of Heme Oxygenase 1 by Nizatidine and Lisinopril in Healthy Subjects Completed National Center for Research Resources (NCRR) Phase 1 To assess if oral nizatidine or lisinopril alone and in combination will increase heme oxygenase 1 (HO-1) protein concentration and activity compared to placebo in healthy subjects.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Nizatidine

Condition Name

Condition Name for Nizatidine
Intervention Trials
Healthy 3
Pulmonary Aspiration of Gastric Contents 1
Community-acquired Pneumonia 1
Heartburn 1
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Condition MeSH

Condition MeSH for Nizatidine
Intervention Trials
Gastroesophageal Reflux 2
Heartburn 1
Respiratory Aspiration of Gastric Contents 1
Pneumonia 1
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Clinical Trial Locations for Nizatidine

Trials by Country

Trials by Country for Nizatidine
Location Trials
United States 16
Canada 1
Brazil 1
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Trials by US State

Trials by US State for Nizatidine
Location Trials
California 2
Nebraska 1
Louisiana 1
Kentucky 1
Georgia 1
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Clinical Trial Progress for Nizatidine

Clinical Trial Phase

Clinical Trial Phase for Nizatidine
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Nizatidine
Clinical Trial Phase Trials
Completed 8
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Clinical Trial Sponsors for Nizatidine

Sponsor Name

Sponsor Name for Nizatidine
Sponsor Trials
Dr. Reddy's Laboratories Limited 2
Eli Lilly and Company 1
Adil Bharucha 1
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Sponsor Type

Sponsor Type for Nizatidine
Sponsor Trials
Other 6
Industry 4
NIH 3
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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Baxter
Mallinckrodt
UBS
Boehringer Ingelheim
Chubb
Cantor Fitzgerald
Julphar
Cipla

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