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An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory Cough

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01703923
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : November 5, 2014
Sponsor:
Information provided by (Responsible Party):
Cerecor Inc

Tracking Information
First Submitted Date  ICMJE October 8, 2012
First Posted Date  ICMJE October 11, 2012
Last Update Posted Date November 5, 2014
Study Start Date  ICMJE November 2012
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
Cough Count/Frequency [ Time Frame: Day 0-1, Day 14-15; Day 28-29, Day 42-43 ]
Change in start-to-end difference in cough count, active vs. placebo treatment periods
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01703923 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2012)
  • LCQ [ Time Frame: Days 0, 14, 28, & 42 ]
    Start-to-end difference in Leicester Cough Questionnaire (LCQ) score, active vs. placebo treatment periods
  • VAS Score [ Time Frame: Days 1, 14, 28, & 42 ]
    Start-to-end difference in Visual analogue scale (VAS) score, active vs. placebo treatment periods
  • Cough Severity Diary [ Time Frame: Days 0, 14, 28, & 42 ]
    Start-to-end difference in CSD score, active vs. placebo treatment periods
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Exploratory Study of FP01 Lozenges in Subjects With Chronic Refractory Cough
Official Title  ICMJE An Exploratory, Randomized, Placebo-Controlled, Double-Blind, Crossover Study of FP01 Lozenges in Subjects With Chronic Refractory Cough
Brief Summary The purpose of this study is to determine the antitussive effect size and dose response of FP01 lozenges in subjects with chronic cough and to demonstrate the safety and tolerability of FP01 lozenges in subjects with chronic cough.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Refractory Cough
Intervention  ICMJE
  • Drug: FP01
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: FP01 6mg or Placebo
    FP01 6mg Oral
    Interventions:
    • Drug: FP01
    • Drug: placebo
  • Experimental: FP01 12mg or Placebo
    FP01 12mg Oral
    Interventions:
    • Drug: FP01
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2013)
83
Original Estimated Enrollment  ICMJE
 (submitted: October 10, 2012)
66
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits
  • Subjects must be able to read and write English
  • Subject must exceed a cough severity threshold (VAS) during screening visit (Cough Severity VAS Score ≥ 35 mm)
  • Mean CSD frequency domain (Only Questions 1-3 at time of screening) score > 3.0
  • Stable chest X-ray
  • Forced expiratory volume 1 (FEV1) and forced vital capacity (FVC) >70% predicted measured using spirometry
  • Body mass index (BMI) 18.5 - 38
  • Subjects must be non-smokers or have refrained from using nicotine or nicotine containing products for at least 6 months
  • Female subjects should be either post-menopausal (amenorrhea for at least 12 consecutive months), surgically sterile, or women of child-bearing potential with a negative serum beta human chorionic gonadotropin 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

Exclusion Criteria:

  • Recent significant change in pulmonary status or upper respiratory tract infection (<4 weeks of randomization)
  • Female subjects who are pregnant, breast feeding or sexually active without contraception.
  • History of chronic obstructive pulmonary disease (COPD)
  • History of asthma that required any significant change in treatment within 2 weeks of randomization. Subjects with asthma are eligible as long as the subject is not being treated with oral steroids but may enroll as long as no new medication to control their asthma has been prescribed within two weeks of study enrollment.
  • History of inhalational exposure (chemical, smoke, water, etc.) within 6 months of randomization
  • Chest X-ray suggestive of granulomatous disease, malignancy, pneumonia, other acute pulmonary or pleural processes
  • Current treatment with angiotensin converting enzyme (ACE) inhibitors
  • Recent myocardial infarction, or history of congestive cardiac failure
  • Active, 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.)
  • Prior or current renal disease; calculated creatinine clearance < 30 mL/min (calculated CrCl < 30)
  • History of Human Immunodeficiency Virus (HIV) or current clinically significant liver disease
  • Use of opioids, neuromodulators (eg., gabapentin, pregabalin) first generation antihistamines (eg., diphenhydramine, chlorpheniramine) or antidepressants for the treatment of cough, during the study. Subjects taking drugs in these classes for chronic cough at time of screening may have them discontinued at least 2 days prior to randomization.
  • Use of other NMDA-receptor antagonists (e.g. dextromethorphan, ketamine, amantadine) within 2 days of randomization
  • Use of any of the following medications which may interact with memantine: quinidine, nicotine, neuroleptics such as chlorpromazine and promethazine, amitriptyline, baclofen, warfarin and hydrochlorothiazide
  • Known hypersensitivity to memantine hydrochloride
  • Observation of oral lesion(s) or abnormal finding(s) on oral cavity examination done at study screening or Day 0
  • History of oropharyngeal leukoplakia, carcinoma or parotid dysfunction
  • Subject has clinically significant abnormal laboratory test results at the screening visit (Subject may be enrolled by exception, as determined by the Principal Investigator and consented by Cerecor's Medical Monitor.)
  • Subject has had clinically significant bleeding or donated blood or plasma within 30 days of randomization
  • Subject has history of alcohol or drug abuse in past 2 years
  • Subject has a positive drug and alcohol screen. Subjects receiving benzodiazepines by prescription, who test positive for benzodiazepines at the screening visit will be allowed.
  • Subjects who have any disease or condition (medical or surgical) that might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, or central nervous system function; or any other conditions that might interfere with the absorption, distribution, metabolism, or excretion of the study drug, or that would place the subject at increased risk, as determined by the Investigator.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01703923
Other Study ID Numbers  ICMJE Clin01-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cerecor Inc
Study Sponsor  ICMJE Cerecor Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Blake Paterson, MD Cerecor Inc
PRS Account Cerecor Inc
Verification Date October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP