Trials by why stopped
- "Tapering doses" protocol arm was not effective for treatment retention outcome.
- (interim) data analysis and funding search
- - Study was terminated due to insufficient clinical efficacy observed in previous studies conducted in postherpetic neuralgia.
- 10/2005 PI temporarily assigned duties as trauma physician in addition to his full time clinical and surgical duties.
- 12/15/2008 Voluntarily placed on inactive status-requested by the PI
- 1st years Enrollment #s showed study was not going to meet criteria randomization.
- 2 complications with midazolam
- 20 subjects completed for a pilot, further funding required to continue study
- 2006 data will be analyzed. Due to few capacities 2011 to 2016 will be supended.
- 2010 represented complications recruiting. The team suffered from sick-leave.
- 3 unexpected Serious Adverse Events (veno-occlusive disease (VOD))
- 36 cases were included and the 4 centers and they are unable to increase their recruitment to obtain the 400 cases necessary to reach statistical significance.
- 40 patients
- 50% of eligible patients refused to enter the study
- 6 month vital status report not collected after 28 day follow up analysis indicated no difference between placebo & tezosentan
- 65 patients were included after 2 years instead of 140
- 7% enrollment. Study terminated after a small number of recruited patients
- A 300 patient safety analysis by the Data Monitoring Committee showed a trend towards higher mortality in the treatment group.
- A business decision not to continue into Phase 2b based on non-safety observations during proof of concept phase.
- A cluster of adverse events in everolimus arm was noted.
