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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerecor Inc
ClinicalTrials.gov Identifier:
NCT01703923
First received: October 8, 2012
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Chronic Refractory Cough
Drug: FP01
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Exploratory, Randomized, Placebo-Controlled, Double-Blind, Crossover Study of FP01 Lozenges in Subjects With Chronic Refractory Cough

Resource links provided by NLM:


Further study details as provided by Cerecor Inc:

Primary Outcome Measures:
  • Cough Count/Frequency [ Time Frame: Day 0-1, Day 14-15; Day 28-29, Day 42-43 ] [ Designated as safety issue: No ]
    Change in start-to-end difference in cough count, active vs. placebo treatment periods


Secondary Outcome Measures:
  • LCQ [ Time Frame: Days 0, 14, 28, & 42 ] [ Designated as safety issue: No ]
    Start-to-end difference in Leicester Cough Questionnaire (LCQ) score, active vs. placebo treatment periods

  • VAS Score [ Time Frame: Days 1, 14, 28, & 42 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Start-to-end difference in CSD score, active vs. placebo treatment periods


Enrollment: 83
Study Start Date: November 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FP01 6mg or Placebo
FP01 6mg Oral
Drug: FP01 Drug: placebo
Experimental: FP01 12mg or Placebo
FP01 12mg Oral
Drug: FP01 Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703923

Locations
United States, California
Allergy & Asthma Associates of Santa Clara Valley
San Jose, California, United States, 95117
United States, Florida
Sher Allergy Specialists
Largo, Florida, United States, 33778
South Florida Clinical Research Trials, LLC
Miami, Florida, United States, 33186
United States, North Carolina
American Health Research
Charlotte, North Carolina, United States, 28207
Wake Research, LLC
Raleigh, North Carolina, United States, 27612
United States, Oklahoma
Oklahoma Institute of Allergy and Asthma
Oklahoma City, Oklahoma, United States, 73131
Allergy, Asthma and Immunology Center, P.C./ Vital Prospects Clinical Research Institute, P.C.
Tulsa, Oklahoma, United States, 74136
United States, Washington
Bellingham Asthma and Allergy Associates
Bellingham, Washington, United States, 98225
Sponsors and Collaborators
Cerecor Inc
Investigators
Study Chair: Blake Paterson, MD Cerecor Inc
  More Information

No publications provided

Responsible Party: Cerecor Inc
ClinicalTrials.gov Identifier: NCT01703923     History of Changes
Other Study ID Numbers: Clin01-003
Study First Received: October 8, 2012
Last Updated: September 12, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014