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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02252926
Other study ID # P2HNC01
Secondary ID
Status Completed
Phase Phase 2
First received September 10, 2014
Last updated August 15, 2016
Start date September 2014
Est. completion date December 2015

Study information

Verified date August 2016
Source Hvidovre University Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Health and Medicines AuthorityDenmark: Ethics CommitteeDenmark: Danish Dataprotection AgencyDenmark: The Good Clinical Practice Unit, Copenhagen
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- diagnosed with head/neck cancer and starting radio therapy treatment

- age between 18 and 80 years (both included)

- able to talk, read and understand Danish

- ability to give informed consent

Exclusion Criteria:

- known hypersensitivity towards bupivacaine or other local anesthetics of the amide type

- pregnancy

- women breastfeeding a child

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine
25 mg bupivacaine lozenge
Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)
Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

Locations

Country Name City State
Denmark Department of Oncology, Rigshospitalet Copenhagen
Denmark Department of Oncology, Herlev Hospital, Denmark Herlev

Sponsors (2)

Lead Sponsor Collaborator
Hvidovre University Hospital Moberg Pharma, Sweden

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS) The primary outcome measure is the mean VAS score for the patients in the bupivacaine lozenge group compared with the mean VAS score for the patients in the standard treatment group.
The lozenge group measures VAS before and 60 min. after administration of a lozenge for seven days. The standard treatment group measures VAS every second hour for seven days.
7 days No
Secondary Duration of the effect of the lozenge Mean value of the pain score (VAS) measured 120 minuts after the administration of a lozenge for the patients receiving the lozenges compared with the mean value of the pain score (VAS) measured every second hour for the patients receiving the standard treatment. 7 days No
Secondary Effect of the bupivacaine lozenge The difference in pain score (VAS) between the first score in the morning before the first lozenge of the day and the score 60 minuts after the administration of the lozenge. Pain is scored both in the oral cavity and the pharynx. 7 days No
Secondary Safety: Peak plasma concentrations of bupivacaine The first ten patients receiving the bupivacaine lozenge will on day seven (the last day of their treatment period) get blood samples drawn before a lozenge is administrated and at time 30 min, 60 min. and 90 min. after the administration. 90 minutes No
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