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Trial record 5 of 11 for:    "Otic Pharma" OR "Novus Therapeutics" OR "Tokai Pharmaceuticals"

Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults

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: NCT03828149
Recruitment Status : Completed
First Posted : February 4, 2019
Results First Posted : December 30, 2019
Last Update Posted : December 30, 2019
Sponsor:
Information provided by (Responsible Party):
Novus Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE January 30, 2019
First Posted Date  ICMJE February 4, 2019
Results First Submitted Date  ICMJE October 30, 2019
Results First Posted Date  ICMJE December 30, 2019
Last Update Posted Date December 30, 2019
Actual Study Start Date  ICMJE February 8, 2019
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2019)
Safety (Evaluation of Adverse Events) [ Time Frame: Days 1-9 ]
All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
Safety (Evaluation of Adverse Events) [ Time Frame: Days 1-9 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
Evaluate the pharmacodynamics of the Eustachian Tube using continuous tympanic impedance measures [ Time Frame: Days 1-9 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Official Title  ICMJE Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo
Brief Summary Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Detailed Description Evaluation of Safety and Pharmacodynamics of OP0201 Compared to Placebo in Healthy Adults
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy Adults
Intervention  ICMJE
  • Combination Product: Drug:OP0201
    Drug: OP0201
  • Combination Product: Drug: Placebo
    Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Drug: OP0201
    20 mg dose one time, followed by a washout and then a 0 mg dose one time, cross over design
    Intervention: Combination Product: Drug:OP0201
  • Placebo Comparator: Drug: Placebo
    0 mg dose one time, followed by a washout and then a 20 mg dose one time, cross over design
    Intervention: Combination Product: 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: March 12, 2019)
17
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2019)
16
Actual Study Completion Date  ICMJE March 7, 2019
Actual Primary Completion Date March 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria includes but is not limited to:

  1. Body Mass Index (BMI) 18 to 30 and a minimum body weight of 50 kg at screening.
  2. No history or presence of significant medical condition or a clinically significant abnormal finding, as determined by the investigator.
  3. Negative urine pregnancy test at screening and baseline for females of childbearing potential
  4. Agree to refrain from water immersion of the ears from the time of signed informed consent to the end of trial
  5. Physiologic tympanogram type A (normal) or type C at screening visit

Exclusion Criteria includes but is not limited to:

  1. Known substance abuse (e.g., alcohol, licit or illicit drugs) within 96 weeks prior to screening visit
  2. Positive urine drug screen at screening visit
  3. Upper respiratory tract infection currently or within 6 weeks prior to screening visit
  4. Allergy or sinus conditions (e.g., sinusitis, non-specific nasal inflammation) currently or within 6 weeks prior to screening visit
  5. Claustrophobia that is sufficient to prevent them tolerating assessments while in a hypobaric/hyperbaric atmospheric pressure chamber
  6. Smoker (e.g ., cigarettes, vapor) within the last 48 weeks prior to screening visit
  7. Clinically significant findings on ear nose and throat exam
  8. Gastroesophageal reflux disease currently or within 6 weeks prior to screening visit
  9. Current diagnosis of sleep apnea
  10. Evidence of craniofacial anomalies (eg, cleft palate, Down's Syndrome) that may interfere with ET function
  11. Disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, Kartagener's syndrome)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03828149
Other Study ID Numbers  ICMJE OP0201-C-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novus Therapeutics, Inc
Study Sponsor  ICMJE Novus Therapeutics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novus Therapeutics, Inc
Verification Date October 2019

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