Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies
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|ClinicalTrials.gov Identifier: NCT01178346|
Recruitment Status : Completed
First Posted : August 10, 2010
Last Update Posted : May 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Biological: NicVAX vaccine Biological: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Health-Related Quality-of-Life and Health-Care Resource Utilization Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Biological: NicVAX vaccine
NicVAX vaccine given 6 times over 6 months
Placebo Comparator: Placebo
Placebo vaccine given 6 times over 6 months
- To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period. [ Time Frame: one year ]QoL and health utilization questionnaires will be used to measure this outcome.
- To estimate utility scores for use in further health-economic models. [ Time Frame: one year ]Scores will be computed from QoL questionnaires to measure this outcome.
- To evaluate health care resource utilization. [ Time Frame: one year ]Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01178346
Show 25 Study Locations
|Study Director:||Medical Monitor||Nabi Biopharmaceuticals|