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Trial record 12 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression

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ClinicalTrials.gov Identifier: NCT01698333
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : September 26, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Therapeutics, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Intervention Drug: 122-0551
Enrollment 25
Recruitment Details

Recruitment period: April 2012 to March 2013

The location of clinical sites included private dermatology clinics and clinical research centers.

Pre-assignment Details All subjects who met the entry criteria were enrolled into the study.
Arm/Group Title 122-0551
Hide Arm/Group Description 122-0551: Applied twice daily for 2 weeks
Period Title: Overall Study
Started 25
Completed 25
Not Completed 0
Arm/Group Title 122-0551
Hide Arm/Group Description 122-0551: Applied twice daily for 2 weeks
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
The Intent-To-Treat (ITT) population included all participants enrolled in the study who were dispensed and applied test article at least once and had at least one follow-up visit after the Baseline visit (Visit 2). All 25 enrolled subjects were included in the ITT population.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
50.7  (11.64)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
10
  40.0%
Male
15
  60.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
6
  24.0%
Not Hispanic or Latino
19
  76.0%
Unknown or Not Reported
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 25 participants
White
21
  84.0%
Asian
3
  12.0%
Islander
1
   4.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 25 participants
25
 100.0%
1.Primary Outcome
Title Hypothalamic-Pituitary-Adrenal (HPA) Axis Response
Hide Description HPA axis response to stimulation by cosyntropin, dichotomized to "normal" and "abnormal". Laboratory evidence of abnormal HPA axis response is defined as a 30-minute post-stimulation serum cortisol level that is ≤ 18 μg/dL at the end of study.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis shown is based on the ITT population, defined as all enrolled participants who applied at least one dose of the test article and returned for at least one post-Baseline visit.
Arm/Group Title 122-0551
Hide Arm/Group Description:
122-0551: Applied twice daily for 2 weeks
Overall Number of Participants Analyzed 25
Measure Type: Count of Participants
Unit of Measure: Participants
Normal
19
  76.0%
Abnormal
6
  24.0%
Time Frame AEs were collected from study screening (performed 20 days or more prior to baseline/first dose) to end of study treatment or participant termination. AEs that continued beyond completion/termination were followed until resolution or stabilization.
Adverse Event Reporting Description The Safety population included all subjects enrolled in the study who were dispensed the test article at least once. Each subject counted once for each AE Term.
 
Arm/Group Title 122-0551
Hide Arm/Group Description 122-0551: Applied twice daily for 2 weeks
All-Cause Mortality
122-0551
Affected / at Risk (%)
Total   0/25 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
122-0551
Affected / at Risk (%) # Events
Total   0/25 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
122-0551
Affected / at Risk (%) # Events
Total   8/25 (32.00%)    
Infections and infestations   
Pharyngitis * 1  1/25 (4.00%)  1
Upper Respiratory Infection * 1  1/25 (4.00%)  1
Injury, poisoning and procedural complications   
Procedural Nausea * 1  1/25 (4.00%)  1
Investigations   
ACTH Stimulation Test Abnormal  1  6/25 (24.00%)  6
Respiratory, thoracic and mediastinal disorders   
Nasal Congestion * 1  1/25 (4.00%)  1
1
Term from vocabulary, MedDRA v15.0
*
Indicates events were collected by non-systematic assessment
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.
The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 12 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 30 days prior to public dissemination. The PI may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Research
Organization: Therapeutics Inc.
Phone: 858-571-1800
EMail: clinicalresearch@therapeuticsinc.com
Layout table for additonal information
Responsible Party: Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01698333     History of Changes
Other Study ID Numbers: 122-0551-202
First Submitted: September 27, 2012
First Posted: October 3, 2012
Results First Submitted: August 30, 2018
Results First Posted: September 26, 2018
Last Update Posted: October 24, 2018