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Trial record 2 of 19 for:    "Secondary Adrenal Insufficiency" | "Respiratory System Agents"

Hydrocortisone Replacement in Patients With Secondary Adrenal Insufficiency (SUPREME CORT) (SUPREME CORT)

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: NCT01546922
Recruitment Status : Completed
First Posted : March 7, 2012
Results First Posted : July 14, 2014
Last Update Posted : July 14, 2014
Sponsor:
Information provided by (Responsible Party):
A.P. van Beek, MD PhD, University Medical Center Groningen

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Adrenal Insufficiency
Intervention Drug: Hydrocortisone
Enrollment 63
Recruitment Details  
Pre-assignment Details Sixty-three patients were included in the study. Three patients withdrew from the study during the run-in phase, therefore a total of 60 patients started the first treatment period.
Arm/Group Title First a Low Dose of HC Followed by a High Dose of HC First a High Dose of HC Followed by a Low Dose of HC
Hide Arm/Group Description First low dose of hydrocortisone = 0.2-0.3 mg/kg body weight for 10 weeks followed by a high dose of hydrocortisone = 0.4-0.6 mg/kg body weight First high dose of hydrocortisone = 0.4-0.6 mg/kg body weight for 10 weeks followed by a low dose of hydrocortisone = 0.2-0.3 mg/kg body weight
Period Title: First Period of 10 Weeks
Started 30 30
Completed 25 28
Not Completed 5 2
Reason Not Completed
Protocol Violation             3             1
Withdrawal by Subject             1             1
Investigator's judgment             1             0
Period Title: Second Period of 10 Weeks
Started 25 28
Completed 22 25
Not Completed 3 3
Reason Not Completed
Protocol Violation             3             1
Withdrawal by Subject             0             2
Arm/Group Title All Participants
Hide Arm/Group Description All participants completing both study periods
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
The 47 participants completing both study periods were used for further analysis.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 47 participants
55
(43 to 61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
18
  38.3%
Male
29
  61.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Netherlands Number Analyzed 47 participants
47
Age at diagnosis  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 47 participants
31
(20 to 46)
Childhood onset/Adult onset  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
Childhood onset 6
Adult onset 41
Body weight  
Median (Inter-Quartile Range)
Unit of measure:  Kilogram
Number Analyzed 47 participants
82.5
(72.2 to 93.0)
Type of surgery   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
Transsphenoïdal surgery 23
Craniotomy 9
[1]
Measure Description: A total of 32 participants underwent surgery
Age at surgery  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 47 participants
39
(28 to 50)
Median time since surgery  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 47 participants
11
(6 to 20)
Patients with a second surgery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
5
Type of radiotherapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
Pituitary radiotherapy 16
Cranial irradiation 2
Radiotherapy for extracranial tumors 1
[1]
Measure Description: A total of 19 participants received radiotherapy
Age at radiotherapy  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 47 participants
43
(25 to 52)
Median time since radiotherapy  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 47 participants
12
(9 to 22)
Total daily dose hydrocortisone treatment prior to randomization  
Median (Inter-Quartile Range)
Unit of measure:  Mg/day
Number Analyzed 47 participants
25
(20 to 30)
Dose per kg body weight prior to randomization  
Median (Inter-Quartile Range)
Unit of measure:  Mg/kg body weight
Number Analyzed 47 participants
0.32
(0.25 to 0.35)
Number of daily dosings prior to randomization  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
1 dose per day 3
2 doses per day 33
3 doses per day 11
Duration of hydrocortisone treatment prior to randomization  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 47 participants
12
(5 to 22)
Number of hormonal replacements  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
1 hormonal replacement 3
2 hormonal replacements 9
3 hormonal replacements 21
4 hormonal replacements 11
5 hormonal replacements 3
Thyroid hormone substitution  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
43
Growth hormone (GH)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
Participants substituted 21
Participants unsubstituted 10
Sex hormone  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
Participants substituted 27
Men: testosterone substitution 23
Premenopausal women: estrogen substitution 4
Desmopressin substitution  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 47 participants
9
1.Primary Outcome
Title Change in Cognition After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.
Hide Description

Cognitive domains to be tested: memory, executive functioning, attention and social cognition.

The psychological tests consist of oral and written questions or computer tasks.

Data is given as Z-scores based on normative data. Higher Z-scores represent a better performance.

Time Frame After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).
Hide Outcome Measure Data
Hide Analysis Population Description
The participants completing both study periods were analyzed
Arm/Group Title Low Dose of Hydrocortisone High Dose of Hydrocortisone
Hide Arm/Group Description:
Results from the participants while receiving the low dose of hydrocortisone
Results from the participants while receiving the high dose of hydrocortisone
Overall Number of Participants Analyzed 47 47
Mean (Standard Deviation)
Unit of Measure: Z-scores based on normative data.
RBMT-Immediate Memory -0.41  (0.95) -0.42  (1.33)
RBMT-Delayed Memory 0.07  (0.98) 0.10  (1.33)
RBMT-Delayed corrected for immediate memory 0.85  (1.09) 0.89  (1.34)
15 Words Test-Short-term memory 0.36  (1.01) -0.03  (1.03)
15 Words Test-Total immediate memory 0.43  (1.02) 0.25  (0.92)
15 Words Test - Learning Score 0.08  (1.05) 0.38  (1.19)
15 Words Test - Delayed Memory 0.02  (1.04) 0.23  (0.97)
15 Words Test - Delayed corrected for total memory -0.30  (0.99) -0.16  (0.99)
15 Words Test-Recognition -0.11  (0.88) 0.08  (0.71)
Digit Span forward - Short term memory 0.49  (0.97) 0.56  (0.97)
Rey Complex Figure - Immediate memory 1.14  (1.26) 1.40  (1.29)
Rey Complex Figure - Delayed memory 1.11  (1.22) 1.28  (1.29)
Divided attention-reaction time auditory response -0.87  (0.81) -0.89  (0.82)
Divided attention-reaction time visual response -0.06  (1.00) 0.03  (0.94)
Divided attention - Number of omission errors -0.02  (0.86) -0.14  (0.93)
Divided attention - Number of commission errors 0.30  (1.01) 0.34  (0.76)
Visual scanning - Reaction time for target stimuli -0.38  (1.04) -0.36  (1.03)
Visual scanning - Number of omission errors -0.03  (1.06) 0.08  (1.08)
Visual scanning - Number of commission errors -0.72  (0.26) -0.70  (0.28)
Alertness - Reaction time tonic alertness -0.90  (0.73) -0.99  (0.73)
Alertness - Reaction time phasic alertness -1.03  (0.67) -1.10  (0.66)
Semantic fluency 0.02  (1.24) 0.09  (1.18)
Phonemic fluency 0.32  (1.48) 0.21  (1.31)
Digit Span backwards-Working memory 0.05  (0.86) -0.01  (1.02)
Trail Making Test - Time condition A -0.32  (1.14) -0.26  (1.06)
Trail Making Test - Time condition B 0.16  (1.46) 0.18  (1.31)
Trail Making Test - Condition B/A 0.37  (1.42) 0.36  (1.48)
Social Cognition -0.67  (1.20) -0.71  (1.15)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Rivermead Behavioural Memory Test (RBMT) - Immediate memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.861
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments RBMT - Delayed memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.668
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments RBMT-Delayed corrected for immediate memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.713
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments 15 Words Test - Short-term memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments 15 Words Test - Total immediate memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.227
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments 15 Words Test - Learning Score
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.130
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments 15 Words Test- Delayed memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.106
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments 15 Words Test - Delayed corrected for total memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.350
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 9 Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments 15 Words Test - Recognition
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 10 Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Digit Span forward - Short-term memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.614
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 11 Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Rey Complex Figure - Immediate memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.111
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 12 Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Rey Complex Figure - Delayed memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.451
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 13 Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Divided attention-Reaction time auditory response
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.905
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 14 Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Divided attention-Reaction time visual response
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.502
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 15 Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Divided attention-Number of omission errors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.531
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 16 Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Divided attention-Number of commission errors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.681
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 17 Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Visual scanning - Reaction time for target stimuli
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.713
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 18 Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Visual scanning - Number of omission errors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.229
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 19 Hide Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Visual scanning - Number of commission errors
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.329
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 20 Hide Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Alertness - Reaction time tonic alertness
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.192
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 21 Hide Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Alertness - Reaction time phasic alertness
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.164
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 22 Hide Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Semantic fluency
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.536
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 23 Hide Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Phonemic fluency
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.572
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 24 Hide Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Digit span backward - Working memory
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.632
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 25 Hide Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Trail Making Test - Time condition A
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.512
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 26 Hide Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Trail Making Test - Time condition B
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.861
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 27 Hide Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Trail Making Test - Condition B/A
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.958
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 28 Hide Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Low Dose of Hydrocortisone, High Dose of Hydrocortisone
Comments Social cognition
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.819
Comments A Bonferroni correction for multiple comparisons was applied, resulting in a significance level of 0.001.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Change in Quality of Life After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.
Hide Description Quality of life questionnaires have to be filled in by the participant at his/her home place and have to be returned by post.
Time Frame After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Change in Metabolic Profile After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.
Hide Description Cardiovascular and metabolic risk factors, (pituitary) hormones and bone markers.
Time Frame After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Change in Somatosensation After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.
Hide Description Measures of somatosensation: the mechanical detection threshold, the mechanical pain threshold, mechanical pain sensitivity, dynamic mechanical allodynia, wind up ratio and the pressure pain threshold.
Time Frame After completion of treatment period 1 (that is after 10 weeks from baseline) and after treatment period 2 (that is after 20 weeks from baseline).
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Change in Perceived Common Somatic Complaints After 10 Weeks of Treatment With a Low Dose of Hydrocortisone Compared to 10 Weeks of Treatment With a High Dose of Hydrocortisone.
Hide Description The patients report common somatic complaints by filling in structured daily diaries.
Time Frame during treatment period 1 (that is from week 1 to week 10 from baseline) and during treatment period 2 (that is from week 11 to week 20 from baseline).
Outcome Measure Data Not Reported
Time Frame 4 weeks run in phase (if applicable) + 10 weeks (treatment period 1) + 10 weeks (treatment period 2)
Adverse Event Reporting Description On testdays patients were questioned to report any adverse events. Furthermore, in week 5 and week 15 of the treatment period, patients were asked if any adverse events happened. In between these assessments patients were able to report any adverse events when necessary.
 
Arm/Group Title Low Dose of HC High Dose of HC
Hide Arm/Group Description Administration of a low dose of hydrocortisone (0.2-0.3 mg/kg body weight) for 10 weeks Administration of a high dose of hydrocortisone (0.4-0.6 mg/kg body weight) for 10 weeks
All-Cause Mortality
Low Dose of HC High Dose of HC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Low Dose of HC High Dose of HC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/58 (1.72%)      1/55 (1.82%)    
Infections and infestations     
Influenza A infection   1/58 (1.72%)  1 0/55 (0.00%)  0
Vascular disorders     
Minor stroke left cerebral hemisphere   0/58 (0.00%)  0 1/55 (1.82%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Low Dose of HC High Dose of HC
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/58 (34.48%)      13/55 (23.64%)    
Cardiac disorders     
Cardiac catheterisation   1/58 (1.72%)  1 0/55 (0.00%)  0
Eye disorders     
Diplopia with operative correction   0/58 (0.00%)  0 1/55 (1.82%)  1
Gastrointestinal disorders     
Gasteroenteritis   0/58 (0.00%)  0 1/55 (1.82%)  1
General disorders     
Tiredness   3/58 (5.17%)  3 1/55 (1.82%)  1
Dizziness   1/58 (1.72%)  1 1/55 (1.82%)  1
Headache   1/58 (1.72%)  1 0/55 (0.00%)  0
Stiffness in joints   1/58 (1.72%)  1 0/55 (0.00%)  0
Nausea   1/58 (1.72%)  1 1/55 (1.82%)  1
Immune system disorders     
Allergic reaction to Ibuprofen   0/58 (0.00%)  0 1/55 (1.82%)  1
Infections and infestations     
Influenza   2/58 (3.45%)  2 1/55 (1.82%)  1
Injury, poisoning and procedural complications     
Broken arm   1/58 (1.72%)  1 0/55 (0.00%)  0
Motorcycle accident   0/58 (0.00%)  0 1/55 (1.82%)  1
Fall from a horse   0/58 (0.00%)  0 1/55 (1.82%)  1
Musculoskeletal and connective tissue disorders     
Joint pain   2/58 (3.45%)  2 2/55 (3.64%)  2
Nervous system disorders     
Sciatica   0/58 (0.00%)  0 1/55 (1.82%)  1
Psychiatric disorders     
Progressive depression   1/58 (1.72%)  1 0/55 (0.00%)  0
Renal and urinary disorders     
Cystitis   1/58 (1.72%)  1 0/55 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash   2/58 (3.45%)  2 0/55 (0.00%)  0
Herpes Zoster   1/58 (1.72%)  1 1/55 (1.82%)  1
Red spots in face   1/58 (1.72%)  1 0/55 (0.00%)  0
Acne on back and forehead   1/58 (1.72%)  1 0/55 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: A. P. van Beek, MD PhD
Organization: University Medical Center Groningen
Phone: 00315036110388
EMail: a.p.van.beek@umcg.nl
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: A.P. van Beek, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01546922     History of Changes
Other Study ID Numbers: NL 35668.042.11
2011-000864-82 ( EudraCT Number )
First Submitted: February 7, 2012
First Posted: March 7, 2012
Results First Submitted: April 25, 2014
Results First Posted: July 14, 2014
Last Update Posted: July 14, 2014