AN EXPLORATORY, RANDOMIZED, PLACEBO CONTROLLED, DOUBLE BLIND, PARALLEL ARM DOSE RANGING STUDY TO DETERMINE THE ANTITUSSIVE EFFECTS OF FPO1 LOZENGES IN SUBJECTS WITH COUGH DUE TO UPPER RESPIRATORY TRACT INFECTIO

CERECOR INC.,0 个研究点目标入组 9 人开始时间: 2012年5月30日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. SUBJECT MUST STATE THAT THEY HAVE HAD A COLD FOR: ≤ 14 DAYS. A COLD IS DEFINED AS:
•A) MODERATE OR SEVERE RHINORRHEA (I.E., USING 2 OR MORE TISSUES PER HOUR FOR ANY 1 HOUR WITHIN 12 HOURS PRECEDING STUDY SCREENING AND
•B) AT LEAST ONE OTHER RESPIRATORY SYMPTOM (COUGH, PHARYNGEAL SYMPTOMS [SORE THROAT], NASAL CONGESTION OF MODERATE OR SEVERE INTENSITY, HEADACHE, ETC.)
•2. SUBJECT MUST EXCEED A COUGH SEVERITY THRESHOLD (VAS) DURING SCREENING VISIT (COUGH SEVERITY VAS SCORE ≥ 40 MM).
•3. SUBJECTS WHO RECALL THAT THEIR AVERAGE NUMBER OF DAYS WITH COUGH DURING THEIR USUAL COLD HISTORY IS 3 OR GREATER (URTI COUGH HISTORY ≥ 3).
•4. SUBJECTS WHO DO NOT SMOKE OR USE NICOTINE OR NICOTINE CONTAINING PRODUCTS. EX-SMOKERS/EX-TOBACCO USERS MUST HAVE STOPPED USING TOBACCO PRODUCTS FOR AT LEAST 6 MONTHS PRIOR TO STUDY SCREENING.
•5. FEMALE SUBJECTS SHOULD BE EITHER POST-MENOPAUSAL (AMENORRHEA FOR AT LEAST 12 CONSECUTIVE MONTHS), SURGICALLY STERILE, OR WOMEN OF CHILD-BEARING POTENTIAL (WOCP) WITH A NEGATIVE SERUM BETA HUMAN CHORIONIC GONADOTROPIN (HCG) PREGNANCY TEST PRIOR TO ENTERING THE STUDY AND WHO ARE USING OR AGREE TO USE AN ACCEPTABLE METHOD OF CONTRACEPTION AS DETERMINED BY THE INVESTIGATOR.

•1. SUBJECT WHO ARE USING ANTIBIOTICS AT STUDY SCREENING OR FOR WHOM ANTIBIOTICS ARE CURRENTLY INDICATED AS DETERMINED BY THE INVESTIGATOR.
•2. HISTORY OF COUGH OF GREATER THAN 6 WEEKS IN DURATION.
•3. HISTORY OF ANY CHRONIC PULMONARY DISEASE INCLUDING TUBERCULOSIS, LUNG CANCER, CHRONIC BRONCHITIS OR EMPHYSEMA
•4. HISTORY OF PNEUMONIA, INFLUENZA OR WHOOPING COUGH WITHIN THE PAST 30 DAYS.
•5. HISTORY OF ASTHMA THAT REQUIRED ANY TREATMENT WITHIN 2 WEEKS OF STUDY
•6. T > 38.5°C WITH NO HISTORY OF ANTI-PYRETIC MEDICATION FOR > 24 HOURS FROM SCREENING VISIT
•7. HISTORY OF INHALATIONAL EXPOSURE (CHEMICAL, SMOKE, WATER, ETC.) WITHIN THE PAST 6 MONTHS.
•8. CHEST X-RAY SUGGESTIVE OF GRANULOMATOUS DISEASE, MALIGNANCY, COPD,
•BRONCHIECTASIS, PNEUMONIA, PLEURAL PROCESSES OR OTHER UNDERLYING
•PULMONARY DISEASE
•9. ACTIVE, CONCURRENT CONCOMITANT DISEASE WHICH MIGHT LIMIT THE ABILITY OF THE SUBJECT TO PARTICIPATE IN THE STUDY AS DETERMINED BY THE INVESTIGATOR (I.E., DIABETES MELLITUS, CONGESTIVE HEART FAILURE, UNSTABLE ANGINA, ETC.)

发起方

CERECOR INC.,