Trial · NCT00836810
Timed Release Tablet Prednisone in Polymyalgia Rheumatica
NCT00836810, Phase 2, Phase 3, Completed, University Hospitals Bristol and Weston NHS Foundation Trust; results first posted 2018-02-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Timed Release Tablet Prednisone in Polymyalgia Rheumatica. Trials, record NCT00836810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00836810
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Timed Release Tablet Prednisone in Polymyalgia Rheumatica
- NCT number
- NCT00836810
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Conditions
- Polymyalgia Rheumatica
- Interventions
- Timed Release Tablet Prednisone, Prednisolone
- First posted
- 2009-02-04
- Last updated
- 2022-09-13
- Results first posted
- 2018-02-05
- Limitations and caveats
- Small number of patients not blind to study treatment which may have influenced reports of morning stiffness.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Peak Serum IL-6 Concentration | 24 hours | 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. |
| Primary | Change in Area Under the Curve (AUC) of Plasma IL-6 | 24 hour measurements 2 weeks apart | 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). |
| Secondary | Percentage Change in Morning Stiffness | 2 weeks | How long was your morning stiffness today? Pre-treatment (Night A) value minus post-treatment (Night B) value divided by pre-treatment value. |
| Secondary | Pain (Severity) | 24 hour period after 2 weeks of treatment | 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. |
| Secondary | Patient's Opinion of Condition | Current value at baseline and after 2 weeks treatment | 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). |
| Secondary | Clinician's Opinion of Disease Activity. | Current at baseline and after 2 weeks treatment | 100mm visual analogue scale. Question: Clinician's opinion of disease activity. Anchors: None; Severe Min 0 Max 100 (worse) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Peak Serum IL-6 Concentration | 24 hours | pg/ml | MEAN | |
| PRIMARY | Change in Area Under the Curve (AUC) of Plasma IL-6 | 24 hour measurements 2 weeks apart | pg*hr/ml | MEAN | |
| SECONDARY | Percentage Change in Morning Stiffness | 2 weeks | percentage of baseline morning stiffness | MEAN | |
| SECONDARY | Pain (Severity) | 24 hour period after 2 weeks of treatment | mm | MEAN | |
| SECONDARY | Patient's Opinion of Condition | Current value at baseline and after 2 weeks treatment | mm | MEAN | |
| SECONDARY | Clinician's Opinion of Disease Activity. | Current at baseline and after 2 weeks treatment | mm | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Peak Serum IL-6 Concentration | Timed Release Tablet Prednisone | 11.5 | Standard Deviation 8.3 | pg/ml | |
| Change in Peak Serum IL-6 Concentration | Standard Prednisolone | 29.3 | Standard Deviation 15.1 | pg/ml | |
| Change in Area Under the Curve (AUC) of Plasma IL-6 | Timed Release Tablet Prednisone | 113.5 | Standard Deviation 77.7 | pg*hr/ml | |
| Change in Area Under the Curve (AUC) of Plasma IL-6 | Standard Prednisolone | 97.9 | Standard Deviation 84.3 | pg*hr/ml | |
| Percentage Change in Morning Stiffness | Timed Release Tablet Prednisone | 75.0 | Standard Deviation 38.7 | percentage of baseline morning stiffness | |
| Percentage Change in Morning Stiffness | Standard Prednisolone | 115.0 | Standard Deviation 55.0 | percentage of baseline morning stiffness | |
| Pain (Severity) | Timed Release Tablet Prednisone | 26.5 | Standard Deviation 25.3 | mm | |
| Pain (Severity) | Standard Prednisolone | 19.5 | Standard Deviation 13.1 | mm | |
| Patient's Opinion of Condition | Timed Release Tablet Prednisone | 17.8 | Standard Deviation 20.6 | mm | |
| Patient's Opinion of Condition | Standard Prednisolone | 26.0 | Standard Deviation 17.6 | mm |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Timed Release Tablet Prednisone | 5 | |
| Overall Study | STARTED | Standard Prednisolone | 6 | |
| Overall Study | COMPLETED | Timed Release Tablet Prednisone | 4 | |
| Overall Study | COMPLETED | Standard Prednisolone | 6 | |
| Overall Study | NOT COMPLETED | Timed Release Tablet Prednisone | 1 | |
| Overall Study | NOT COMPLETED | Standard Prednisolone | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Timed Release Tablet Prednisone | 0 | 4 |
| Total, all-cause mortality | Standard Prednisolone | 0 | 6 |
| Total, other adverse events | Timed Release Tablet Prednisone | 0 | 4 |
| Total, other adverse events | Standard Prednisolone | 0 | 4 |
| Total, serious adverse events | Timed Release Tablet Prednisone | 0 | 4 |
| Total, serious adverse events | Standard Prednisolone | 0 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Timed Release Tablet Prednisone vs Standard Prednisolone: deaths from any cause | Trial comparisons |
| Timed Release Tablet Prednisone vs Standard Prednisolone: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00836810
GET https://conductscience.org/api/trials/v1/NCT00836810/registered