Pilot Study to Evaluate the Safety and Analgesic Activity of M40403 Co-Administered With an Opioid Agent for Cancer Pain
M40403 was found to be effective in reducing pain in animal models and in clinical studies of subjects who were experiencing pain after dental surgery. The proposed study is designed to investigate the efficacy and safety of M40403 when co-administered with an opioid in subjects with pain due to cancer.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo Controlled, Multi-Center, Pilot Study to Evaluate the Safety and Analgesic Activity of M40403 Co-Administered With an Opioid Agent in a Cancer Pain Model|
- To evaluate the safety and analgesic activity of a single dose of 0.25 mg/kg (or the highest tolerated dose from the open-label phase) of M40403 co-administered with current pain medication in subjects experiencing moderate to severe pain.
- To evaluate safety and analgesic activity of ascending, single doses of M40403 (0.0625, 0.125, and 0.25mg/kg) co-administered with current pain medication and to assess the pharmacokinetic parameters of a single dose of M40403.
|Study Start Date:||August 2004|
|Estimated Study Completion Date:||August 2005|
The proposed study is designed to investigate the efficacy, safety, and pharmacokinetics of M40403 in subjects with pain related to cancer. Because the effects of M40403 have not been previously investigated in subjects with cancer-related pain, the safety of single doses of 0.0625, 0.125, and 0.25 mg/kg of M40403 will be evaluated in an open label phase of the study. These doses of M40403 are similar to doses that were used in subjects who were experiencing pain in prior clinical studies with M40403.