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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Other
Condition Healthy Adults
Interventions Combination Product: Drug:OP0201
Combination Product: Drug: Placebo
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Drug: OP0201 First, Then Placebo Drug: Placebo First, Then OP0201
Hide Arm/Group Description

Participants first received 20mg one time dose of OP0201, followed by a washout and then a single dose of Placebo, cross over design

Drug:OP0201: Drug: OP0201

Participants first received 0 mg one time dose of Placebo, followed by a washout and then a single dose of OP0201, cross over design

Drug: Placebo: Drug: Placebo

Period Title: First Intervention (Single Dose)
Started 9 8
Completed 9 8
Not Completed 0 0
Period Title: Washout (6 Days)
Started 9 8
Completed 9 8
Not Completed 0 0
Period Title: Second Intervention (Single Dose)
Started 9 8
Completed 9 8
Not Completed 0 0
Arm/Group Title Drug: OP0201 First, Then Placebo Drug: Placebo First, Then OP0201 Total
Hide Arm/Group Description

Participants first received 20mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design

Drug:OP0201: Drug: OP0201

Participants first received 0 mg one time dose, followed by a washout and then a single dose of the opposite intervention, cross over design

Drug: Placebo: Drug: Placebo

Total of all reporting groups
Overall Number of Baseline Participants 9 8 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 9 participants 8 participants 17 participants
27.0  (5.7) 24.5  (3.9) 25.8  (5.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
Female
5
  55.6%
4
  50.0%
9
  52.9%
Male
4
  44.4%
4
  50.0%
8
  47.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 8 participants 17 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
9
 100.0%
8
 100.0%
17
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Germany Number Analyzed 9 participants 8 participants 17 participants
9
 100.0%
8
 100.0%
17
 100.0%
1.Primary Outcome
Title Safety (Evaluation of Adverse Events)
Hide Description All randomized participants who received at least one spray of study treatment in either nare were included in the safety analysis.
Time Frame Days 1-9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Drug: OP0201 Drug: Placebo
Hide Arm/Group Description:

Participants received 20mg OP0201 one time dose at Day 1 or Day 8.

Drug:OP0201: Drug: OP0201

Participants received 0 mg one time dose at Day 1 or Day 8.

Drug: Placebo: Drug: Placebo

Overall Number of Participants Analyzed 17 17
Measure Type: Count of Participants
Unit of Measure: Participants
17
 100.0%
17
 100.0%
Time Frame 9 days
Adverse Event Reporting Description The safety population included all randomized participants who received at least one spray of study treatment in either nare.
 
Arm/Group Title OP0201 Placebo
Hide Arm/Group Description

Participants received OP0201 20mg one time dose at either Day 1 or Day 8.

Drug:OP0201: Drug: OP0201

Participants received Placebo 0 mg one time dose at either Day 1 or Day 8.

Drug: Placebo: Drug: Placebo

All-Cause Mortality
OP0201 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Hide Serious Adverse Events
OP0201 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/17 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OP0201 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   12/17 (70.59%)   14/17 (82.35%) 
Ear and labyrinth disorders     
Ear Pain   8/17 (47.06%)  10/17 (58.82%) 
Tympanic membrane hyperaemia   6/17 (35.29%)  5/17 (29.41%) 
Tympanic membrane disorder   4/17 (23.53%)  3/17 (17.65%) 
Ear discomfort   1/17 (5.88%)  1/17 (5.88%) 
General disorders     
Fatigue   1/17 (5.88%)  1/17 (5.88%) 
Peripheral swelling   0/17 (0.00%)  1/17 (5.88%) 
Nervous system disorders     
Headache   1/17 (5.88%)  4/17 (23.53%) 
Dizziness   1/17 (5.88%)  1/17 (5.88%) 
Respiratory, thoracic and mediastinal disorders     
Nasal discomfort   2/17 (11.76%)  1/17 (5.88%) 
Rhinorrhoea   0/17 (0.00%)  2/17 (11.76%) 
Nasal injury   1/17 (5.88%)  0/17 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Director
Organization: Novus Therapeutics
Phone: 949-679-1110
EMail: study001@novustherapeutics.com
Layout table for additonal information
Responsible Party: Novus Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT03828149    
Other Study ID Numbers: OP0201-C-001
First Submitted: January 30, 2019
First Posted: February 4, 2019
Results First Submitted: October 30, 2019
Results First Posted: December 30, 2019
Last Update Posted: December 30, 2019