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A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy With Oral Vonoprazan 20 mg or Double-Blind Triple Therapy With Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy With Oral Lansoprazole 30 mg Daily in Patients With Helicobacter Pylori Infection

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Trial Profile

A Phase 3 Randomized Multicenter Study to Evaluate the Efficacy and Safety of Open-Label Dual Therapy With Oral Vonoprazan 20 mg or Double-Blind Triple Therapy With Oral Vonoprazan 20 mg Compared to Double-Blind Triple Therapy With Oral Lansoprazole 30 mg Daily in Patients With Helicobacter Pylori Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Nov 2023

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At a glance

  • Drugs Vonoprazan (Primary) ; Amoxicillin; Clarithromycin; Lansoprazole
  • Indications Helicobacter pylori infections
  • Focus Registrational; Therapeutic Use
  • Acronyms PHALCON-HP
  • Sponsors Phathom Pharmaceuticals

Most Recent Events

  • 30 Oct 2023 According to a Phathom Pharmaceuticals media release, company plans to host an investor conference call in November 2023, following FDA action on the pending Erosive GERD New Drug Application, which has a PDUFA target action date of November 17, to discuss the Company's U.S. commercial launch plans.
  • 30 Oct 2023 According to a Phathom Pharmaceuticals media release, company announced that the U.S. Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) for the reformulation of vonoprazan tablets for both VOQUEZNA TRIPLE PAK (vonoprazan tablets, amoxicillin capsules, clarithromycin tablets) and VOQUEZNA DUAL PAK (vonoprazan tablets, amoxicillin capsules), for the treatment of Helicobacter pylori (H. pylori) infection in adults based on safety and efficacy data from the Phase 3.
  • 09 May 2023 Sub-group analysis (N=992) presented at the Digestive Disease Week 2023.

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