drugset / Trial / NCT00489255

Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment

NCT00489255

Phase 4 Completed 117 enrolled Ipsen INC Research Limited · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®

Timeline

Start
2007-05
Primary completion
2011-12
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Trimethobenzamide Small molecule 300 mg Oral

Indications