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INDICATION VOQUEZNA® Triple Pak® is indicated for the treatment of Helicobacter pylori infection in adults READ MORE

pHalcon-HP: The largest phase 3 study conducted in H. pylori infection1,2

A randomized, controlled, double-blind triple therapy/open-label dual therapy study that evaluated the effectiveness and safety of VOQUEZNA® Triple Pak® (vonoprazan, amoxicillin, clarithromycin) and VOQUEZNA® Dual Pak® (vonoprazan, amoxicillin) in the United States and Europe.

VOQUEZNA Triple Pak and VOQUEZNA Dual Pak vs a traditional PPI-based triple therapy

Study Group
N=1046* treatment-naive
adults testing H. pylori positive who have at least 1 clinical condition
Randomized Treatment Period: 14 Days
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VOQUEZNA Triple Pak
(n =346)
Vonoprazan 20 mg, 2× Daily
Clarithromycin 500 mg, 2× Daily
Amoxicillin 1000 mg, 2× Daily
VOQUEZNA Dual Pak
(n =348)
Vonoprazan 20 mg, 2× Daily
Amoxicillin 1000 mg, 3× Daily
Lansoprazole Triple Therapy
(n =345)
Lansoprazole 30 mg, 2× Daily
Clarithromycin 500 mg, 2× Daily
Amoxicillin 1000 mg, 2× Daily

Study Details

  • Clinical conditions included: dyspepsia lasting at least 2 weeks, functional dyspepsia, recent/new diagnosis of peptic ulcer, peptic ulcer not treated for H. pylori infection, or a stable dose of long-term NSAID treatment
  • H. pylori eradication was confirmed with a negative 13C UBT test-of-cure at ≥27 days after therapy
*Of the total study group, 1039 was the actual number of patients who received at least 1 dose of study drug.
Noninferiority to lansoprazole triple therapy in participants who did not have
a clarithromycin- or amoxicillin-resistant strain of H. pylori
Superiority to lansoprazole triple therapy
in all participants with H. pylori infection
Superiority to lansoprazole triple therapy
in participants with a clarithromycin-resistant strain of H. pylori

Analysis sets1,2

Modified intent-to-treat (mITT): Patients were included in the mITT analysis if they had documented H. pylori infection at baseline.

Per protocol (PP): Patients were included in the per-protocol analysis if they had documented H. pylori infection at baseline, had a test-of-cure visit conducted in the protocol-specified window, took at least 75% of each study drug, and did not take excluded medications (other antimicrobials known to be effective against H. pylori, proton pump inhibitors, or high-dose H2-receptor antagonists).

SEE ERADICATION RESULTS