A Multicentre Study to Evaluate the Safety and Efficacy of AD 923 in Comparison to MSIR for the Treatment of CBP in Subjects
|ClinicalTrials.gov Identifier: NCT00635063|
Recruitment Status : Terminated (Termination is due to a combination of a device defect potentially impacting the quality of the AD 923 IMP and a major change in corporate strategy.)
First Posted : March 13, 2008
Last Update Posted : June 6, 2008
The purpose of this study is to compare the efficacy and safety of AD 923 to the most widely used current treatment (MSIR) in the management of target BTP in subjects with malignancies who are taking a stable dose of background opioids. The efficacy evaluation criteria have been designed to determine whether AD 923 provides superior analgesia compared with MSIR as measured by the primary endpoint.
|Condition or disease||Intervention/treatment||Phase|
|Cancer Pain||Drug: AD 923||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicentre, Randomised, Double-Blind, Double-Dummy, Crossover Study to Evaluate the Safety and Efficacy of AD 923 (Fentanyl Sublingual) in Comparison to Morphine Sulphate Immediate Release (MSIR) for the Treatment of Breakthrough Pain in Subjects With Malignancies|
|Study Start Date :||February 2008|
|Experimental: AD 923||Drug: AD 923|
|Active Comparator: MSIR||Drug: AD 923|
- To evaluate the efficacy of AD 923 in comparison to MSIR in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.
- To assess the safety and tolerability of AD 923 in the management of breakthrough pain in subjects with malignancies who are taking a stable dose of background opioids.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00635063
|Sosei R&D Ltd|
|Saffron Walden, Essex, United Kingdom, CB10 1XL|
|Principal Investigator:||Andrew Davies, MBBS||Royal Marsden NHS Foundation Trust|