Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cerecor Inc
ClinicalTrials.gov Identifier:
NCT01597349
First received: May 9, 2012
Last updated: January 27, 2014
Last verified: January 2014
  Purpose

The purpose of this research study is to learn how effective and safe FP01 lozenges are when given to subjects with a cough due to an upper respiratory tract infection. The study will include subjects who have an upper respiratory tract infection, with a cough of less than six weeks duration.


Condition Intervention Phase
Acute Cough
Drug: FP01
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: An Exploratory, Randomized, Placebo Controlled, Double Blind, Parallel Arm Dose Ranging Study to Determine the Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection

Resource links provided by NLM:


Further study details as provided by Cerecor Inc:

Primary Outcome Measures:
  • Change in cough count, active vs placebo treatment period [ Time Frame: Daily for 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: Daily over 3 days ] [ Designated as safety issue: Yes ]
    The evaluation of treatment safety will take into account the recorded adverse events, vital signs, clinical and laboratory assessments and the buccal cavity examination


Enrollment: 208
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FP01 High dose Drug: FP01
Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.
Experimental: FP01 Low dose Drug: FP01
Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.
Placebo Comparator: Placebo Drug: FP01
Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

gastroesophageal INCLUSION CRITERIA

  1. Subject must state that they have had a "cold" for < 14 days. A "cold" is defined as:

    • Moderate or severe rhinorrhea (i.e., using 2 or more tissues per hour for any 1 hour within 12 hours preceding study screening AND
    • 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. Acceptable contraceptives include abstinence OR intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable) for ≥ three months prior to screening OR use of double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
  6. Subject must sign an Institutional Review Board approved informed consent and agree to complete required clinic visits.

EXCLUSION CRITERIA

  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 > 38.5oC 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.)
  10. Prior or current renal disease; calculated creatinine clearance < 30 ml/min (calculated ClCr < 30)
  11. Known immune deficiency condition
  12. Use of opioids or anticonvulsants within 3 days of study screening.
  13. Known hypersensitivity to memantine or lozenge excipients.
  14. Current oral lesions or abnormal findings on buccal examination done at study screening.
  15. History of oropharyngeal or gastroesophageal carcinoma, or gastro/esophageal/duodenal resection.
  16. 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.)
  17. Any clinically significant finding on the ECG done at the screening visit, as determined by the investigator. (Subject may be enrolled by exception, as determined by the Principal Investigator and consented by Cerecor's Medical Monitor).
  18. Female subjects who are pregnant, breast feeding or sexually active without contraception.
  19. Subject has donated blood or plasma within the last 45 days.
  20. Subject has history of alcohol or drug abuse in past 2 years.
  21. Subject has a positive drug screen.
  22. Subject has a positive HIV, Hepatitis B or Hepatitis C test.
  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: NCT01597349

Locations
Chile
Clinica Las Lilas
Santiago, Chile, 7510524
Biomedical Research Group
Santiago, Chile
Peru
Clinica Internacional Sede Lima
Lima, Peru
Unidad de Investigación Clinica San Pablo
Lima, Peru
Clinica Internacional Sede San Borja
Lima, Peru
Sponsors and Collaborators
Cerecor Inc
  More Information

No publications provided

Responsible Party: Cerecor Inc
ClinicalTrials.gov Identifier: NCT01597349     History of Changes
Other Study ID Numbers: CLIN01-002-A
Study First Received: May 9, 2012
Last Updated: January 27, 2014
Health Authority: United States: Food and Drug Administration
Chile: Ministry of Health
Peru: Ministry of Health

Additional relevant MeSH terms:
Cough
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Infection
Antitussive Agents
Guaifenesin
Phenylpropanolamine
Chlorpheniramine, phenylpropanolamine drug combination
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Respiratory System Agents
Expectorants
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 31, 2014