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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. Identifier: NCT01703923
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : November 5, 2014
Information provided by (Responsible Party):
Cerecor Inc

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.

Condition or disease Intervention/treatment Phase
Chronic Refractory Cough Drug: FP01 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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
Study Start Date : November 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cough

Arm Intervention/treatment
Experimental: FP01 6mg or Placebo
FP01 6mg Oral
Drug: FP01
Drug: placebo
Experimental: FP01 12mg or Placebo
FP01 12mg Oral
Drug: FP01
Drug: placebo

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. LCQ [ Time Frame: Days 0, 14, 28, & 42 ]
    Start-to-end difference in Leicester Cough Questionnaire (LCQ) score, active vs. placebo treatment periods

  2. VAS Score [ Time Frame: Days 1, 14, 28, & 42 ]
    Start-to-end difference in Visual analogue scale (VAS) score, active vs. placebo treatment periods

  3. Cough Severity Diary [ Time Frame: Days 0, 14, 28, & 42 ]
    Start-to-end difference in CSD score, active vs. placebo treatment periods

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01703923

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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
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Study Chair: Blake Paterson, MD Cerecor Inc
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Responsible Party: Cerecor Inc Identifier: NCT01703923    
Other Study ID Numbers: Clin01-003
First Posted: October 11, 2012    Key Record Dates
Last Update Posted: November 5, 2014
Last Verified: October 2014
Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory