Spots Global Cancer Trial Database for A Pharmacokinetic Study of Single Doses of Sativex in Treatment-induced Mucositis

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Trial Identification

Brief Title: A Pharmacokinetic Study of Single Doses of Sativex in Treatment-induced Mucositis

Official Title: An Open-label Clinical Trial to Compare the Pharmacokinetics of up to 4 Single Oromucosal Doses of 4 Sprays of Sativex® in Patients With Treatment Induced Mild, Moderate and Severe Oral Mucositis (Grade 1 - 3 RTOG Oral Mucositis) With Their Pharmacokinetic Profile Pre-treatment (When Mucositis-free)

Study ID: NCT01975688

Conditions

Head and Neck Squamous Cell Carcinoma

Interventions

Sativex

Study Description

Brief Summary: To investigate what the body does to single doses of Sativex (i.e. the pharmacokinetics \[PKs\] of four sprays containing 10.8 mg Δ9 tetrahydrocannabinol \[THC\] and 10 mg cannabidiol \[CBD\]) when mild, moderate or severe oral mucositis is induced. This will be done by looking at the effects of the body on the drug before and after oral mucositis is induced. The study participants will have Non-surgical Head and Neck Squamous Cell Carcinoma (HNSCC), and oral mucositis will be induced with radiotherapy and/or chemotherapy.

Detailed Description: