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bicarbonate

Phase 3

Gastric Acid | Small molecule | Gastrointestinal |Bausch + Lomb Corporation|Last Updated: Mar 11, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

bicarbonate · 1 trial · 2 indications

Phase 3 1
NCT00674115A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)Gastric Acid
COMPLETED60 Analytics
PHASE3COMPLETED
A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17 )(P07813)(COMPLETED)
Gastric AcidUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Median 24-hour Intragastric pH on the 7th Day of Drug Administration
Baseline and 7 days

The change from Baseline in median pH was calculated as: median pH on Day 7 minus median pH at Baseline. PH measures how acidic or basic a substance is. The pH scale ranges from 0 to 14. A pH of 7 is neutral. A pH less than 7 is acidic. A pH greater than 7 is basic.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER

Treatment Arms

ArmTypeDescription
Single Dose Zegerid for 1 or 7 daysEXPERIMENTALOmeprazole 20 mg/Sodium Bicarbonate 1680 mg Powder for Oral Suspension
Single Dose Prilosec 1 or 7 daysACTIVE_COMPARATOROmeprazole magnesium 20 mg over-the-counter (OTC) Tablet
Sodium BicarbonateACTIVE_COMPARATORSodium Bicarbonate 1680 mg Oral Suspension

Interventions

NameTypeDescription
Omeprazole/sodium bicarbonateDRUGOmeprazole/sodium bicarbonate. Single dose per day for either 1 or 7 days.
omeprazole magnesiumDRUGOmeprazole 20 mg tablet. Single dose per day for either 1 or 7 days.
sodium bicarbonateDRUGSodium bicarbonate. Single dose.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Normal subjects who are 18-65 years of age. * Non-childbearing potential females or those using birth control. Exclusion Criteria: * History of hypersensitivity, allergy or intolerance to omeprazole or other proton pump inhibitors * History of significant gastrointestinal di...

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Competitive Landscape -Gastric Cancer 112 trials (matched to "Gastric Acid")

Top 20 of 45 competitors

CompanyTickerTrialsLead PhaseDrugs
AstraZeneca PLCAZN16PHASE3AZD0901, Ramucirumab, paclitaxel, Paclitaxel, Docetaxel
BeOne Medicines Ltd. Sponsored ADRONC4PHASE3Tislelizumab, Cisplatin, Leucovorin, 5-fluorouracil, Oxaliplatin
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE3Zanidatamab, Tislelizumab, Trastuzumab, Capecitabine, Oxaliplatin
Arcus Biosciences, Inc.RCUS2PHASE3Domvanalimab, Zimberelimab, Capecitabine, Fluorouracil, Leucovorin
Bristol-Myers Squibb CompanyBMY6PHASE2Pumitamig, Folfox, Capox, Nivolumab
Pfizer Inc.PFE7PHASE2disitamab vedotin, tucatinib
Agenus Inc.AGEN2PHASE3Balstilimab, Botensilimab, Folfox Protocol, XELOX, Nivolumab
AbbVie, Inc.ABBV2PHASE2Telisotuzumab Adizutecan, Budigalimab, Fluorouracil, Leucovorin, Oxaliplatin
Eli Lilly and CompanyLLY2PHASE2Ramucirumab, Paclitaxel
Compass Therapeutics, Inc.CMPX1PHASE2CTX-009, Paclitaxel
ALX Oncology Holdings, Inc.ALXO1PHASE2Evorpacept, Trastuzumab, Ramucirumab, Paclitaxel
GE Healthcare Technologies Inc.GEHC1PHASE2GEH300079 Positron-Emission Tomography/Computed Tomography
ImmunityBio IncIBRX1PHASE2N-803, Pembrolizumab
Apollomics Inc. Class AAPLM1PHASE2APL-101
Exelixis, Inc.EXEL2PHASE1cabozantinib, atezolizumab
Tango Therapeutics, Inc.TNGX2PHASE2Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen, Nivolumab
Inhibrx Biosciences, Inc.INBX1PHASE1INBRX-106- Hexavalent OX40 agonist antibody, pembrolizumab, Carboplatin AUC-5, Pemetrexed/m2, Cisplatin/m2
Incyte CorporationINCY1PHASE2Capecitabine, Oxaliplatin, Retifanlimab
I-Mab Biopharma US LimitedIMAB2PHASE2Givastomig, Nivolumab, 5Fluorouracil, Leucovorin, Oxaliplatin
Enliven Therapeutics, Inc.ELVN1PHASE1ELVN-002, Trastuzumab, 5-Fluorouracil, Oxaliplatin, Capecitabine
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Frequently asked questions about bicarbonate

What is bicarbonate used for?

Bicarbonate is an investigational small molecule being developed for gastric acid conditions. It is currently in Phase 3 clinical development. The drug is being studied for its effects on gastric acid, with a completed Phase 3 trial involving 60 participants.

Who makes bicarbonate?

Bicarbonate is being developed by Bausch + Lomb Corporation, which trades under the ticker BLCO. The company is conducting clinical research on this investigational drug for gastric acid conditions.

What phase is bicarbonate in?

Bicarbonate is in Phase 3 clinical development. It has completed one Phase 3 trial, which was an active-controlled, randomized study. The drug is still investigational and has not been approved by regulatory authorities.

What clinical trials is bicarbonate in?

Bicarbonate has one completed clinical trial registered as NCT00674115. This Phase 3 study, titled "A Pharmacodynamic Study Comparing Zegerid® and Prilosec OTC® (CL2007-17)(P07813)", enrolled 60 participants and evaluated gastric acid conditions in healthy volunteers.

Is bicarbonate the same as Zegerid or Prilosec?

Bicarbonate was studied in a clinical trial comparing it to Zegerid and Prilosec OTC. However, the drug itself is a separate investigational compound. The trial was active-controlled, meaning it compared bicarbonate against these other treatments for gastric acid.