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Trial record 43 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

Timed Release Tablet Prednisone in Polymyalgia Rheumatica

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ClinicalTrials.gov Identifier: NCT00836810
Recruitment Status : Completed
First Posted : February 4, 2009
Results First Posted : February 2, 2018
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospitals Bristol NHS Foundation Trust

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Polymyalgia Rheumatica
Interventions Drug: Timed Release Tablet Prednisone
Drug: Prednisolone
Enrollment 12
Recruitment Details Of 35 sequential eligible patients invited to participate 12 agreed to do so.
Pre-assignment Details One patient was a technical failure (unable to take 24 hour blood samples) before the treatment randomisation step, leaving 11 patients included.
Arm/Group Title Timed Release Tablet Prednisone Standard Prednisolone
Hide Arm/Group Description

11 patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.

11 patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

Period Title: Overall Study
Started 5 6
Completed 4 [1] 6
Not Completed 1 0
Reason Not Completed
New diagnosis             1             0
[1]
1 patient was subsequently diagnosed with SLE and, per protocol, was not included.
Arm/Group Title Timed Release Tablet Prednisone Standard Prednisolone Total
Hide Arm/Group Description

Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.

Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

Total of all reporting groups
Overall Number of Baseline Participants 4 6 10
Hide Baseline Analysis Population Description
Fewer participants were recruited than anticipateed within the time frame of the trial.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 6 participants 10 participants
77.5
(67 to 79)
72.5
(67 to 79)
76
(67 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 6 participants 10 participants
Female
3
  75.0%
4
  66.7%
7
  70.0%
Male
1
  25.0%
2
  33.3%
3
  30.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 4 participants 6 participants 10 participants
4 6 10
plasma IL-6 peak values (pg/ml)  
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 4 participants 6 participants 10 participants
53.5  (46.7) 40.1  (22.3) 45.5  (32.4)
plasma IL-6 AUC  
Mean (Standard Deviation)
Unit of measure:  Pg*hr/ml
Number Analyzed 4 participants 6 participants 10 participants
191  (232) 236  (246) 218  (228)
plasma viscosity (mPa.s)  
Median (Full Range)
Unit of measure:  mPa.s
Number Analyzed 4 participants 6 participants 10 participants
1.77
(1.73 to 1.9)
1.875
(1.75 to 2.13)
1.8
(1.73 to 2.13)
Morning stiffness  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 4 participants 6 participants 10 participants
75  (38.7) 115  (55) 96.7  (48.3)
Pain   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 4 participants 6 participants 10 participants
54.8  (23.6) 62.2  (15.0) 59.2  (25.1)
[1]
Measure Description: VAS 0mm (better) -100mm (worse)
Patient's opinion of condition  
Mean (Standard Deviation)
Unit of measure:  VAS 0mm (better) - 100mm (worse)
Number Analyzed 4 participants 6 participants 10 participants
54.8  (29.3) 64.2  (16.3) 60.4  (21.4)
Clinician's opinion of disease activity  
Mean (Standard Deviation)
Unit of measure:  VAS 0mm (better) - 100mm (worse)
Number Analyzed 4 participants 6 participants 10 participants
54.8  (23.6) 62.0  (15.0) 59.1  (18.0)
Polymyalgia Rheumatica Disease Activity Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 4 participants 6 participants 10 participants
29.1  (8.7) 47.1  (22.2) 39.9  (19.6)
[1]
Measure Description:

PMR Disease Activity Score (PMR-AS). Formula:

PMR-AS = C-reactive protein (mg/L) + visual analogue scale, patient (0[better]-10[worse] cm) + visual analogue scale, physician (0[better]-10[worse] cm) + morning stiffness (min) x 0.1 + elevation of the upper limbs (3 = none; 2 = below shoulder girdle; 1 = up to shoulder girdle; 0 = above shoulder girdle)

A score below 7 implies low disease activity, a score range of 7 – 17 reflects medium activity and a score of more than 17 indicates an active disease.

1.Primary Outcome
Title Change in Peak Serum IL-6 Concentration
Hide Description Pre-treatment (Night A) peak minus post-treatment (Night B) peak. Peaks defined as the highest value for each patient from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B) and the peak identified for each one.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Timed Release Tablet Prednisone Standard Prednisolone
Hide Arm/Group Description:

Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.

Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: pg/ml
11.5  (8.3) 29.3  (15.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A priory test for statistical significance was P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone, Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments A priori statistical significance set as P<0.05
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Change in Area Under the Curve (AUC) of Plasma IL-6
Hide Description Pre-treatment (Night A) AUC minus post-treatment (Night B) AUC. AUC calculated from measures at 0, 1.5, 3, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 10.5, 11.5, 12.5, 13.5, 14.5, 15.5, 17, 19, 20.5, 22, and 24 hours after 16.30 on day before treatment (Night A) and last day of treatment (Night B).
Time Frame 24 hour measurements 2 weeks apart
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Timed Release Tablet Prednisone Standard Prednisolone
Hide Arm/Group Description:

Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.

Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: pg*hr/ml
113.5  (77.7) 97.9  (84.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method t-test, 2 sided
Comments A priori statistical significance set at P<0.05
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone, Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Percentage Change in Morning Stiffness
Hide Description How long was your morning stiffness today? Pre-treatment (Night A) value minus post-treatment (Night B) value divided by pre-treatment value.
Time Frame 2 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Timed Release Tablet Prednisone Standard Prednisolone
Hide Arm/Group Description:

Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.

Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: percentage of baseline morning stiffness
75.0  (38.7) 115.0  (55.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0906
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone, Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.044
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title Pain (Severity)
Hide Description 100mm visual analogue scale. Question: How much pain have you had in the last 24 hours? Anchors: No pain; Severe pain. Min score 0, Max score 100. Higher value is worse outcome.
Time Frame 24 hour period after 2 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Timed Release Tablet Prednisone Standard Prednisolone
Hide Arm/Group Description:

Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.

Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: mm
26.5  (25.3) 19.5  (13.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.007
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone, Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.57
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Patient's Opinion of Condition
Hide Description 100mm visual analogue scale. Question: Considering all the ways your pain and/or stiffness affect(s) you, please mark on the line how well you are doing. Anchors: Very well; Very badly. Min 0 Max 100 (poor outcome).
Time Frame Current value at baseline and after 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Timed Release Tablet Prednisone Standard Prednisolone
Hide Arm/Group Description:

Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.

Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: mm
17.8  (20.6) 26.0  (17.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone, Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.51
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title Clinician's Opinion of Disease Activity.
Hide Description 100mm visual analogue scale. Question: Clinician's opinion of disease activity. Anchors: None; Severe Min 0 Max 100 (worse)
Time Frame Current at baseline and after 2 weeks treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Timed Release Tablet Prednisone Standard Prednisolone
Hide Arm/Group Description:

Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.

Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: mm
19.0  (18.1) 20.3  (9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .003
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Timed Release Tablet Prednisone, Standard Prednisolone
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.88
Comments A priori statistical significance set at P<0.05
Method t-test, 2 sided
Comments [Not Specified]
Time Frame 2 week duration of treatment and 2 weeks of standard treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Timed Release Tablet Prednisone Standard Prednisolone
Hide Arm/Group Description

Patients will be taking the intervention night time timed release tablet (TRT) prednisone at a dose of 7mg a day over 2 weeks.

Timed Release Tablet Prednisone: Dose: 7mg, taken at 10pm every night for 2 weeks in the form of oral tablets.

Patients will be taking morning Prednisolone at a dose of 7mg over 2 weeks.

Prednisolone: Dose: 7mg, taken in the morning for 2 weeks in the form of oral tablets.

All-Cause Mortality
Timed Release Tablet Prednisone Standard Prednisolone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/6 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Timed Release Tablet Prednisone Standard Prednisolone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Timed Release Tablet Prednisone Standard Prednisolone
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/4 (0.00%) 
Small number of patients not blind to study treatment which may have influenced reports of morning stiffness.
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
Name/Title: Professor John Kirwan
Organization: University of Bristol
Phone: +44 117 342 2904
Responsible Party: University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00836810     History of Changes
Other Study ID Numbers: ME/2008/3031
First Submitted: February 2, 2009
First Posted: February 4, 2009
Results First Submitted: February 1, 2017
Results First Posted: February 2, 2018
Last Update Posted: February 2, 2018