Trial Outcomes & Findings for Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica (NCT NCT00668434)
NCT ID: NCT00668434
Last Updated: 2015-04-28
Results Overview
The Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
269 participants
Primary outcome timeframe
Baseline, Week 3 follow-up
Results posted on
2015-04-28
Participant Flow
Participant milestones
| Measure |
Prednisone
Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
|
Placebo
Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.
|
|---|---|---|
|
Primary Outcome Time Point (3 Weeks)
STARTED
|
181
|
88
|
|
Primary Outcome Time Point (3 Weeks)
COMPLETED
|
179
|
88
|
|
Primary Outcome Time Point (3 Weeks)
NOT COMPLETED
|
2
|
0
|
|
Secondary Outcome Time Point (52 Weeks)
STARTED
|
179
|
88
|
|
Secondary Outcome Time Point (52 Weeks)
COMPLETED
|
157
|
77
|
|
Secondary Outcome Time Point (52 Weeks)
NOT COMPLETED
|
22
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Oral Prednisone in Improving Physical Functioning and Decreasing Pain in People With Sciatica
Baseline characteristics by cohort
| Measure |
Prednisone
n=181 Participants
Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
|
Placebo
n=88 Participants
Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.
|
Total
n=269 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
46.0 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
149 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
24 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
34 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
181 participants
n=5 Participants
|
88 participants
n=7 Participants
|
269 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 3 follow-upThe Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.
Outcome measures
| Measure |
Prednisone
n=179 Participants
Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
|
Placebo
n=88 Participants
Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.
|
|---|---|---|
|
Oswestry Disability Index, v2
|
-19.0 units on a scale
Standard Error 1.4
|
-13.3 units on a scale
Standard Error 1.7
|
SECONDARY outcome
Timeframe: Baseline, Week 3 follow-upOrdinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.
Outcome measures
| Measure |
Prednisone
n=179 Participants
Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
|
Placebo
n=88 Participants
Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.
|
|---|---|---|
|
Pain Numerical Rating Scale
|
-3.0 units on a scale
Standard Error 0.2
|
-2.8 units on a scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline, Week 52 follow-upThe Oswestry Disability Index, v2 is a back-pain-specific measure of disability and functional status. It is measured on a 0-to-100 scale, with higher numbers indicating greater disability.
Outcome measures
| Measure |
Prednisone
n=157 Participants
Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
|
Placebo
n=77 Participants
Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.
|
|---|---|---|
|
Oswestry Disability Index, v2
|
-37.8 units on a scale
Standard Error 1.5
|
-30.4 units on a scale
Standard Error 2.2
|
SECONDARY outcome
Timeframe: Baseline, Week 52 follow-upOrdinal scale of average level of pain as perceived by the participant over the prior 3 days; measured on a 0-to-10 scale, with higher numbers indicating greater pain.
Outcome measures
| Measure |
Prednisone
n=157 Participants
Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
|
Placebo
n=77 Participants
Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.
|
|---|---|---|
|
Pain Numerical Rating Scale
|
-5.2 units on a scale
Standard Error 0.2
|
-4.6 units on a scale
Standard Error 0.3
|
Adverse Events
Prednisone
Serious events: 3 serious events
Other events: 143 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 63 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Prednisone
n=181 participants at risk
Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
|
Placebo
n=88 participants at risk
Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.
|
|---|---|---|
|
Renal and urinary disorders
Partial nephrectomy
|
0.00%
0/181 • Entire study period, up to 52 weeks
|
1.1%
1/88 • Number of events 1 • Entire study period, up to 52 weeks
|
|
Blood and lymphatic system disorders
Deep venous thrombosis
|
0.55%
1/181 • Number of events 1 • Entire study period, up to 52 weeks
|
0.00%
0/88 • Entire study period, up to 52 weeks
|
|
Gastrointestinal disorders
Upper GI bleed
|
0.00%
0/181 • Entire study period, up to 52 weeks
|
1.1%
1/88 • Number of events 1 • Entire study period, up to 52 weeks
|
|
Gastrointestinal disorders
Appendectomy
|
0.55%
1/181 • Number of events 1 • Entire study period, up to 52 weeks
|
0.00%
0/88 • Entire study period, up to 52 weeks
|
|
Psychiatric disorders
Suicide attempt
|
0.55%
1/181 • Number of events 1 • Entire study period, up to 52 weeks
|
0.00%
0/88 • Entire study period, up to 52 weeks
|
Other adverse events
| Measure |
Prednisone
n=181 participants at risk
Participants will receive a 15-day tapering course of prednisone capsules.
Prednisone: For participants who weigh 50 kg or more, the prednisone dose will be 60 mg daily for 5 days, then 40 mg daily for 5 days, and then 20 mg daily for 5 days. For participants who weigh less than 50 kg, the dose will be 40 mg daily for 10 days, and then 20 mg daily for 5 days.
|
Placebo
n=88 participants at risk
Participants will receive a 15-day course of placebo capsules.
Placebo: Placebo capsules will look the same as the study medication but will not contain active medicine.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular problem
|
1.7%
3/181 • Number of events 4 • Entire study period, up to 52 weeks
|
0.00%
0/88 • Entire study period, up to 52 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatologic problem
|
9.9%
18/181 • Number of events 56 • Entire study period, up to 52 weeks
|
11.4%
10/88 • Number of events 27 • Entire study period, up to 52 weeks
|
|
Ear and labyrinth disorders
Ear or eye disorder
|
0.00%
0/181 • Entire study period, up to 52 weeks
|
2.3%
2/88 • Number of events 6 • Entire study period, up to 52 weeks
|
|
Gastrointestinal disorders
Gastrointestinal problem
|
22.7%
41/181 • Number of events 85 • Entire study period, up to 52 weeks
|
9.1%
8/88 • Number of events 32 • Entire study period, up to 52 weeks
|
|
Renal and urinary disorders
Genitourinary problem
|
1.7%
3/181 • Number of events 8 • Entire study period, up to 52 weeks
|
2.3%
2/88 • Number of events 8 • Entire study period, up to 52 weeks
|
|
Nervous system disorders
Neurologic problem
|
9.4%
17/181 • Number of events 62 • Entire study period, up to 52 weeks
|
15.9%
14/88 • Number of events 34 • Entire study period, up to 52 weeks
|
|
Psychiatric disorders
Psychiatric disorder
|
26.0%
47/181 • Number of events 78 • Entire study period, up to 52 weeks
|
17.0%
15/88 • Number of events 36 • Entire study period, up to 52 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary problem
|
0.55%
1/181 • Number of events 8 • Entire study period, up to 52 weeks
|
0.00%
0/88 • Entire study period, up to 52 weeks
|
|
Renal and urinary disorders
Kidney problem
|
0.00%
0/181 • Entire study period, up to 52 weeks
|
1.1%
1/88 • Number of events 2 • Entire study period, up to 52 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal
|
7.2%
13/181 • Number of events 45 • Entire study period, up to 52 weeks
|
12.5%
11/88 • Number of events 29 • Entire study period, up to 52 weeks
|
Additional Information
Dr. Andrew Avins
Kaiser Permanente, Northern California
Phone: 510-891-3557
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place