Pharmacoeconomic Assessment in Nabi-4514 and Nabi-4515 Phase 3 Studies

Phase 3

Completed

• Conditions: Smoking Cessation

• Registration Number: NCT01178346
• Lead Sponsor: Nabi Biopharmaceuticals

Brief Summary

The purpose of this study is to look at pharmacoeconomic data for subjects that have received either NicVAX or placebo in the Nabi-4514 or Nabi-4515 studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-06
• Study First Posted: 2010-08-10
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-08
• Last Update Posted: 2012-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Subjects who are eligible for randomization or have not reached Week 12 in Nabi-4514 or Nabi-4515 studies.
• Subjects who agree to participate in health-related quality of life study.

Exclusion Criteria

• Subjects who are unable to complete a HRQoL questionnaire because of inability to understand the language or due to mental impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of NicVAX vs. placebo on HRQoL over the study period.	one year	QoL and health utilization questionnaires will be used to measure this outcome.

Secondary Outcome Measures

Name	Time	Method
To estimate utility scores for use in further health-economic models.	one year	Scores will be computed from QoL questionnaires to measure this outcome.
To evaluate health care resource utilization.	one year	Health care visits, medications, hospitalizations and medical procedures will be collected to measure this outcome.

Trial Locations

Locations (2)

NicVAX Investigator; 🇺🇸 Madison, Wisconsin, United States

NicVAX; 🇺🇸 Indianapolis, Indiana, United States