Common Contracts
1 similar Clinical Study Protocol contracts
Investigator Agreement: I have read the protocol and agree to conduct the study as outlined herein.Clinical Study Protocol • May 23rd, 2007
TITLE OF STUDY Serbian Smoking Reduction/Cessation Trial (2SRT) INVESTIGATORS & STUDY CENTERS Professor Robert Nilsson, Stockholm, International Coordinating InvestigatorDr Ruza Antic, Belgrade, Principal National Investigator Participants will be recruited at four centers in the city of Belgrade, Serbia PHASE OFDEVELOPMENT Phase III OBJECTIVES To assess the efficacy of a traditional Swedish smokeless tobacco product (“snus”) to reduce smoking among adult smokers in Serbia DESIGN Randomized, placebo-controlled, double-blind trial PLANNED SAMPLESIZE 500 DIAGNOSIS AND KEYSUBJECT SELECTION CRITERIA Males and females in good general health aged 20-65 years regularlysmoking >10 cigarettes per day for more than 1 year, who are motivated to reduce or quit smoking TREATMENTS 1. Traditional, low-nitrosamine Swedish snus in 0.5 or 1.0 g sachets ad libitum2. Placebo snus (without tobacco or nicotine) MAIN PARAMETERS OF EFFICACY Primary end-point:• “Smoking reduction” at 24 weeks, defined as a sel
