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Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

NCT02252926 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2016-08-16

No results posted yet for this study

Summary

Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and painful adverse effect caused by the radio therapy and/or chemo therapy patients with head and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the current treatment with opioids is not sufficient and can cause adverse effects.

Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce the oral pain caused by mucositis compared with the current standard treatment.

Conditions

Interventions

DRUG

Bupivacaine

25 mg bupivacaine lozenge

DRUG

Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)

Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

Sponsors & Collaborators

  • Moberg Pharma, Sweden

    collaborator UNKNOWN

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Claus A Kristensen, MD, PhD · Department of Oncology, Rigshospitalet, Denmark

  • Jens Bentzen, MD · Department of Oncology Herlev Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02252926 on ClinicalTrials.gov