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Pilot Study to Characterize and Examine the Pharmacokinetics and Efficacy of Chronocort® in Adults With CAH

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ClinicalTrials.gov Identifier: NCT01735617
Recruitment Status : Completed
First Posted : November 28, 2012
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Diurnal Limited

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Endocrine Disease
Adrenal Insufficiency
Congenital Adrenal Hyperplasia
Intervention Drug: Hydrocortisone Modified Release Capsules
Enrollment 16
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hydrocortisone Modified Release Capsules
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Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Period Title: Overall Study
Started 16
Completed 16
Not Completed 0
Arm/Group Title Hydrocortisone Modified Release Capsules
Hide Arm/Group Description

Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Overall Number of Baseline Participants 16
Hide Baseline Analysis Population Description
All treated subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 16 participants
28.7  (12.97)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
Female
8
  50.0%
Male
8
  50.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   6.3%
White
13
  81.3%
More than one race
1
   6.3%
Unknown or Not Reported
1
   6.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 16 participants
16
1.Primary Outcome
Title Pharmacokinetic Profile (Cmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
Hide Description The maximum plasma concentration (Cmax) of chronocort
Time Frame 24 hours
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All treated subjects
Arm/Group Title Chronocort
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Chronocort Modified Release Capsules 10 mg twice-daily.
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: nmol/L
601.213  (114.5987)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Chronocort
Comments The pharmacokinetic profile was characterised by an overnight rise in cortisol levels reaching a maximal concentration approximately 8 hours post dosing.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Geometric means
Estimated Value 563.38
Parameter Dispersion
Type: Standard Deviation
Value: 162.51
Estimation Comments [Not Specified]
2.Primary Outcome
Title Pharmacokinetic Profile (AUC0-24) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
Hide Description Area under the curve (AUC) from 0 to 24 hours (sampling occurs at the following timepoints: 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)
Time Frame 24 hours (at 2300, 0100, 0300, 0500, 0600, 0700, 0800, 0900, 1000, 1100, 1200, 1300, 1400, 1500, 1600, 1700, 1900, 2100, 2300hrs)
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All treated subjects
Arm/Group Title Chroncort
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Chronocort Modified Release Capsules 10mg twice-daily
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: h*nmol/L
5027.641  (1247.8425)
3.Primary Outcome
Title Pharmacokinetic Profile (Tmax) Following Short-term Treatment With Chronocort® in Adult Patients With Congenital Adrenal Hyperplasia
Hide Description Time to maximum plasma concentration (tmax)
Time Frame 24 hours
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All treated subjects
Arm/Group Title Chronocort
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Chronocort Modified Release Capsules 10mg twice-daily
Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: Hours
7.9  (2.9)
4.Secondary Outcome
Title The Percentage of Patients With 17-OHP and Androstenedione Levels at 0700h Within Proposed Optimal Ranges Whilst on Chronocort and Whilst on Standard Therapy (at Baseline)
Hide Description Proposed optimal ranges of 17-OHP: 300-1200ng/dl Proposed optimal ranges of androstenedione: 40-150ng.dl for males and 30-200ng/dl for females
Time Frame Specific time point (0700hrs)
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocortisone Modified Release Capsules
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Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Overall Number of Participants Analyzed 16
Measure Type: Number
Unit of Measure: percentage of participants
17-OHP (baseline) 0
17-OHP (final visit) 12.5
Androstenedione (baseline) 56.3
Androstenedione (final visit) 81.3
5.Secondary Outcome
Title 17-OHP Levels at 0700h, 1700h and 2300h
Hide Description 17-OHP levels at 0700h, 1700h and 2300h
Time Frame Specified time points (0700h, 1700h and 2300h)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocortisone Modified Release Capsules
Hide Arm/Group Description:

Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: nmol/L
17-OHP: Part A, Days 1-2 (0700h) 76.97  (91.986)
17-OHP: Part A, Days 1-2 (1700h) 70.99  (104.106)
17-OHP: Part A, Days 1-2 (2300h) 55.35  (93.632)
17-OHP: Part A, Days 4-5 (0700h) 7.72  (8.231)
17-OHP: Part A, Days 4-5 (1700h) 23.55  (66.046)
17-OHP: Part A, Days 4-5 (2300h) 27.27  (55.140)
17-OHP: Part B, Visit 2 (0700h) 24.86  (54.086)
17-OHP: Part B, Visit 2 (1700h) 15.17  (20.400)
17-OHP: Part B, Visit 2 (2300h) 26.65  (51.185)
17-OHP: Part B, Visit 3 (0700h) 34.87  (49.072)
17-OHP: Part B, Visit 3 (1700h) 13.81  (20.700)
17-OHP: Part B, Visit 3 (2300h) 18.95  (28.276)
17-OHP: Part B, Visit 4 (0700h) 13.67  (19.091)
17-OHP: Part B, Visit 4 (1700h) 34.70  (69.876)
17-OHP: Part B, Visit 4 (2300h) 22.19  (46.826)
6.Secondary Outcome
Title Androstenedione Levels at 0700h, 1700h and 2300h
Hide Description Androstenedione levels at 0700h, 1700h and 2300h
Time Frame Specified time points (0700h, 1700h and 2300h)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocortisone Modified Release Capsules
Hide Arm/Group Description:

Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: nmol/L
Androstenedione: Part A, Days 1-2 (0700h) 7.92  (8.474)
Androstenedione: Part A, Days 1-2 (1700h) 7.54  (7.966)
Androstenedione: Part A, Days 1-2 (2300h) 7.43  (9.388)
Androstenedione: Part A, Days 4-5 (0700h) 3.11  (2.178)
Androstenedione: Part A, Days 4-5 (1700h) 4.62  (8.005)
Androstenedione: Part A, Days 4-5 (2300h) 5.37  (8.340)
Androstenedione: Part B, Visit 2 (0700h) 4.96  (6.731)
Androstenedione: Part B, Visit 2 (1700h) 3.47  (3.094)
Androstenedione: Part B, Visit 2 (2300h) 3.79  (3.748)
Androstenedione: Part B, Visit 3 (0700h) 4.57  (3.561)
Androstenedione: Part B, Visit 3 (1700h) 3.61  (2.713)
Androstenedione: Part B, Visit 3 (2300h) 3.91  (3.103)
Androstenedione: Part B, Visit 4 (0700h) 3.40  (1.973)
Androstenedione: Part B, Visit 4 (1700h) 4.19  (4.602)
Androstenedione: Part B, Visit 4 (2300h) 3.37  (2.655)
7.Secondary Outcome
Title ACTH Levels at 0700h, 1700h and 2300h
Hide Description ACTH levels at 0700h, 1700h and 2300h
Time Frame Specified time points (0700h, 1700h and 2300h)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocortisone Modified Release Capsules
Hide Arm/Group Description:

Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: pmol/L
ACTH: Part A, Days 1-2 (0700h) 21.06  (29.767)
ACTH: Part A, Days 1-2 (1700h) 20.93  (30.121)
ACTH: Part A, Days 1-2 (2300h) 7.75  (9.873)
ACTH: Part A, Days 4-5 (0700h) 4.16  (9.190)
ACTH: Part A, Days 4-5 (1700h) 4.71  (7.382)
ACTH: Part A, Days 4-5 (2300h) 7.37  (7.990)
ACTH: Part B, Visit 2 (0700h) 7.02  (12.159)
ACTH: Part B, Visit 2 (1700h) 5.57  (6.769)
ACTH: Part B, Visit 2 (2300h) 8.66  (14.637)
ACTH: Part B, Visit 3 (0700h) 9.66  (12.418)
ACTH: Part B, Visit 3 (1700h) 4.71  (6.331)
ACTH: Part B, Visit 3 (2300h) 6.04  (7.997)
ACTH: Part B, Visit 4 (0700h) 12.18  (29.911)
ACTH: Part B, Visit 4 (1700h) 13.66  (22.851)
ACTH: Part B, Visit 4 (2300h) 9.44  (17.474)
8.Secondary Outcome
Title AUC Values (Nmol*h/L) for Androstenedione
Hide Description AUC values (nmol*h/L) for Androstenedione for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h
Time Frame Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocortisone Modified Release Capsules
Hide Arm/Group Description:

Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: nmol*h/L
Androstenedione: Part A, Days 1-2 AUC (2300-2300h) 166.19  (171.969)
Androstenedione: Part A, Days 1-2 AUC (2300-0700h) 41.42  (34.133)
Androstenedione: Part A, Days 1-2 AUC (0700-1500h) 65.33  (76.337)
Androstenedione: Part A, Days 1-2 AUC (1500-2300h) 59.44  (65.995)
Androstenedione: Part A, Days 4-5 AUC (2300-2300h) 104.37  (128.725)
Androstenedione: Part A, Days 4-5 AUC (2300-0700h) 36.02  (40.225)
Androstenedione: Part A, Days 4-5 AUC (0700-1500h) 32.01  (31.503)
Androstenedione: Part A, Days 4-5 AUC (1500-2300h) 37.91  (58.394)
Androstenedione: Part B, Visit 2 AUC (2300-2300h) 88.58  (86.364)
Androstenedione: Part B, Visit 2 AUC (2300-0700h) 35.12  (43.580)
Androstenedione: Part B, Visit 2 AUC (0700-1500h) 26.07  (22.298)
Androstenedione: Part B, Visit 2 AUC (1500-2300h) 27.39  (23.989)
Androstenedione: Part B, Visit 3 AUC (2300-2300h) 91.46  (65.295)
Androstenedione: Part B, Visit 3 AUC (2300-0700h) 33.25  (26.255)
Androstenedione: Part B, Visit 3 AUC (0700-1500h) 27.92  (16.297)
Androstenedione: Part B, Visit 3 AUC (1500-2300h) 30.30  (26.188)
Androstenedione: Part B, Visit 4 AUC (2300-2300h) 86.27  (70.892)
Androstenedione: Part B, Visit 4 AUC (2300-0700h) 29.09  (23.314)
Androstenedione: Part B, Visit 4 AUC (0700-1500h) 27.03  (20.009)
Androstenedione: Part B, Visit 4 AUC (1500-2300h) 30.13  (28.797)
9.Secondary Outcome
Title AUC Values (Nmol*h/L) for 17-OHP
Hide Description AUC values (nmol*h/L) for 17-OHP for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h
Time Frame Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocortisone Modified Release Capsules
Hide Arm/Group Description:

Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: nmol*h/L
17-OHP: Part A, Days 1-2 AUC 2300-2300h 1407.83  (1829.291)
17-OHP: Part A, Days 1-2 AUC 2300-0700h 243.99  (339.580)
17-OHP: Part A, Days 1-2 AUC 0700-1500h 607.74  (805.822)
17-OHP: Part A, Days 1-2 AUC 1500-2300h 556.11  (769.492)
17-OHP: Part A, Days 4-5 AUC 2300-2300h 446.90  (817.074)
17-OHP: Part A, Days 4-5 AUC 2300-0700h 169.83  (268.178)
17-OHP: Part A, Days 4-5 AUC 0700-1500h 91.53  (147.801)
17-OHP: Part A, Days 4-5 AUC 1500-2300h 190.73  (425.505)
17-OHP: Part B, Visit 2 AUC 2300-2300h 395.65  (587.533)
17-OHP: Part B, Visit 2 AUC 2300-0700h 168.01  (337.666)
17-OHP: Part B, Visit 2 AUC 0700-1500h 82.41  (91.708)
17-OHP: Part B, Visit 2 AUC 1500-2300h 145.24  (215.115)
17-OHP: Part B, Visit 3 AUC 2300-2300h 432.02  (393.897)
17-OHP: Part B, Visit 3 AUC 2300-0700h 152.63  (144.576)
17-OHP: Part B, Visit 3 AUC 0700-1500h 139.21  (147.353)
17-OHP: Part B, Visit 3 AUC 1500-2300h 140.18  (182.786)
17-OHP: Part B, Visit 4 AUC 2300-2300h 436.54  (678.052)
17-OHP: Part B, Visit 4 AUC 2300-0700h 101.33  (148.003)
17-OHP: Part B, Visit 4 AUC 0700-1500h 120.32  (172.134)
17-OHP: Part B, Visit 4 AUC 1500-2300h 214.89  (364.641)
10.Secondary Outcome
Title AUC Values (Pmol*h/L) for ACTH
Hide Description AUC values (pmol*h/L) for ACTH for the following reporting periods: 24 hours (2300-2300h), 2300-0700h, 0700-1500h and 1500-2300h
Time Frame Specific time points (2300-2300h, 2300-0700h, 0700-1500h and 1500-2300h)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Hydrocortisone Modified Release Capsules
Hide Arm/Group Description:

Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

Overall Number of Participants Analyzed 16
Mean (Standard Deviation)
Unit of Measure: pmol*h/L
ACTH: Part A, Days 1-2 AUC (2300-2300h) 356.25  (415.949)
ACTH: Part A, Days 1-2 AUC (2300-0700h) 54.72  (70.267)
ACTH: Part A, Days 1-2 AUC (0700-1500h) 166.18  (206.294)
ACTH: Part A, Days 1-2 AUC (1500-2300h) 135.35  (169.002)
ACTH: Part A, Days 4-5 AUC (2300-2300h) 120.00  (121.454)
ACTH: Part A, Days 4-5 AUC (2300-0700h) 52.22  (62.067)
ACTH: Part A, Days 4-5 AUC (0700-1500h) 21.29  (19.824)
ACTH: Part A, Days 4-5 AUC (1500-2300h) 47.13  (57.145)
ACTH: Part B, Visit 2 AUC (2300-2300h) 125.45  (118.081)
ACTH: Part B, Visit 2 AUC (2300-0700h) 43.09  (46.711)
ACTH: Part B, Visit 2 AUC (0700-1500h) 34.14  (48.423)
ACTH: Part B, Visit 2 AUC (1500-2300h) 48.22  (49.078)
ACTH: Part B, Visit 3 AUC (2300-2300h) 154.10  (172.474)
ACTH: Part B, Visit 3 AUC (2300-0700h) 50.02  (57.268)
ACTH: Part B, Visit 3 AUC (0700-1500h) 52.46  (64.571)
ACTH: Part B, Visit 3 AUC (1500-2300h) 51.63  (70.735)
ACTH: Part B, Visit 4 AUC (2300-2300h) 252.30  (420.220)
ACTH: Part B, Visit 4 AUC (2300-0700h) 58.80  (107.955)
ACTH: Part B, Visit 4 AUC (0700-1500h) 110.58  (329.386)
ACTH: Part B, Visit 4 AUC (1500-2300h) 82.92  (120.287)
Time Frame Approximately 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hydrocortisone Modified Release Capsules
Hide Arm/Group Description

Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response

Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment

All-Cause Mortality
Hydrocortisone Modified Release Capsules
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Hydrocortisone Modified Release Capsules
Affected / at Risk (%) # Events
Total   0/16 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Hydrocortisone Modified Release Capsules
Affected / at Risk (%) # Events
Total   16/16 (100.00%)    
Blood and lymphatic system disorders   
Anaemia * 1  7/16 (43.75%)  9
General disorders   
Fatigue * 1  13/16 (81.25%)  13
Asthenia * 1  5/16 (31.25%)  5
Investigations   
Weight increase * 1  7/16 (43.75%)  7
Metabolism and nutrition disorders   
Appetite decrease * 1  7/16 (43.75%)  7
Appetite increase * 1  6/16 (37.50%)  6
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  5/16 (31.25%)  5
Nervous system disorders   
Headache * 1  13/16 (81.25%)  13
Dizziness * 1  8/16 (50.00%)  8
Psychiatric disorders   
Insomnia * 1  5/16 (31.25%)  5
Skin and subcutaneous tissue disorders   
Acne * 1  5/16 (31.25%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (16.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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: CEO
Organization: Diurnal Ltd.
Phone: +44 (0) 871 716 8848
EMail: info@diurnal.co.uk
Layout table for additonal information
Responsible Party: Diurnal Limited
ClinicalTrials.gov Identifier: NCT01735617     History of Changes
Other Study ID Numbers: DIUR-003
First Submitted: November 20, 2012
First Posted: November 28, 2012
Results First Submitted: June 25, 2015
Results First Posted: May 17, 2017
Last Update Posted: May 17, 2017