A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.

Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. The sores usually start in the third week of radiation and last aboutfive weeks, often continuing for two weeks after treatment ends. Current pain treatments, for instance lidocaine solution, only give short-lasting pain relief. BupiZenge is a lozenge that dissolves slowly in the mouth and contains bupivacaine. Bupivacaine is a long-acting pain-relieving medicine and has been safely used for man

Trial Details

NCT ID
NCT07672236
Phase
PHASE3
Sponsor
OncoZenge AB
Status
RECRUITING
Cancer Type
Head and Neck Cancer
Interventions
  • BupiZenge 25 mg
  • Lidocaine viscous 2%
Locations (sample)
  • Copenhagen, Denmark|55.67594,12.56553
  • Herlev, Denmark|55.72366,12.43998
  • Næstved, Denmark|55.22992,11.76092
  • Cologne, Germany|50.93333,6.95
  • Frankfurt am Main, Germany|50.11552,8.68417

Key Eligibility Criteria

  • Participant must provide signed written informed consent prior to trial participation and must be willing and able to comply with all requirements …
  • Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing.
  • Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.
  • About to start IMRT with curative intent with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative intended dose of at least 60 Gy and a maximum of …

For full eligibility, visit ClinicalTrials.gov.

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