Trial Outcomes & Findings for Prevention of Pegfilgrastim-Induced Bone Pain (PIBP) (NCT NCT00602420)
NCT ID: NCT00602420
Last Updated: 2015-11-09
Results Overview
Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)\*Days.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
510 participants
Primary outcome timeframe
From baseline through day 5
Results posted on
2015-11-09
Participant Flow
Participant milestones
| Measure |
Naproxen
Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days.
|
Placebo
Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days.
|
|---|---|---|
|
Overall Study
STARTED
|
257
|
253
|
|
Overall Study
COMPLETED
|
232
|
229
|
|
Overall Study
NOT COMPLETED
|
25
|
24
|
Reasons for withdrawal
| Measure |
Naproxen
Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days.
|
Placebo
Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days.
|
|---|---|---|
|
Overall Study
Death
|
1
|
4
|
|
Overall Study
Chemotoxicity, Inc. Data,Ineligible
|
5
|
3
|
|
Overall Study
Withdrawal by Subject
|
18
|
17
|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Baseline characteristics by cohort
| Measure |
Naproxen
n=257 Participants
Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days.
|
Placebo
n=253 Participants
Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days.
|
Total
n=510 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.6 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
56.8 years
STANDARD_DEVIATION 11.1 • n=7 Participants
|
56.2 years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
222 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
437 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
228 Participants
n=5 Participants
|
227 Participants
n=7 Participants
|
455 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
257 participants
n=5 Participants
|
253 participants
n=7 Participants
|
510 participants
n=5 Participants
|
|
Tumor Type
Breast
|
175 participants
n=5 Participants
|
166 participants
n=7 Participants
|
341 participants
n=5 Participants
|
|
Tumor Type
Gynecologic
|
16 participants
n=5 Participants
|
13 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Tumor Type
Hematologic
|
18 participants
n=5 Participants
|
17 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Tumor Type
Lung
|
22 participants
n=5 Participants
|
31 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Tumor Type
Other
|
26 participants
n=5 Participants
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Marital Status
Married
|
181 participants
n=5 Participants
|
179 participants
n=7 Participants
|
360 participants
n=5 Participants
|
|
Marital Status
Not Married
|
72 participants
n=5 Participants
|
72 participants
n=7 Participants
|
144 participants
n=5 Participants
|
|
Marital Status
Unknown
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Education
Some college
|
180 participants
n=5 Participants
|
164 participants
n=7 Participants
|
344 participants
n=5 Participants
|
|
Education
High school or less
|
73 participants
n=5 Participants
|
87 participants
n=7 Participants
|
160 participants
n=5 Participants
|
|
Education
Other
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Previous tamoxifen
Yes
|
8 participants
n=5 Participants
|
11 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Previous tamoxifen
No
|
245 participants
n=5 Participants
|
240 participants
n=7 Participants
|
485 participants
n=5 Participants
|
|
Previous tamoxifen
Unknown
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Previous chemotherapy
Yes
|
60 participants
n=5 Participants
|
75 participants
n=7 Participants
|
135 participants
n=5 Participants
|
|
Previous chemotherapy
No
|
193 participants
n=5 Participants
|
176 participants
n=7 Participants
|
369 participants
n=5 Participants
|
|
Previous chemotherapy
Unknown
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Previous Radiation Therapy
Yes
|
18 participants
n=5 Participants
|
30 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Previous Radiation Therapy
No
|
235 participants
n=5 Participants
|
221 participants
n=7 Participants
|
456 participants
n=5 Participants
|
|
Previous Radiation Therapy
Unknown
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Pain at its worst in last 24 hours (scale, 0-10)
|
1.78 units on a scale
STANDARD_DEVIATION 2.24 • n=5 Participants
|
1.87 units on a scale
STANDARD_DEVIATION 2.23 • n=7 Participants
|
1.83 units on a scale
STANDARD_DEVIATION 2.24 • n=5 Participants
|
|
Bone pain today or during previous 3 days (scale, 0-10)
|
0.47 units on a scale
STANDARD_DEVIATION 1.44 • n=5 Participants
|
0.64 units on a scale
STANDARD_DEVIATION 1.60 • n=7 Participants
|
0.56 units on a scale
STANDARD_DEVIATION 1.52 • n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline through day 5Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary. Patients recorded daily pain (Pain Scale Score) severity on a scale of 0 (no pain) to 10 (pain as bad as you can imagine) for the last 24 hours. The AUC range was 0-40, and the units are (Pain Scale Score)\*Days.
Outcome measures
| Measure |
Naproxen
n=232 Participants
Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days.
|
Placebo
n=229 Participants
Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days.
|
|---|---|---|
|
Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule.
|
6.04 (Pain Scale Score)*Days
Interval 4.94 to 7.14
|
7.71 (Pain Scale Score)*Days
Interval 6.59 to 8.84
|
Adverse Events
Naproxen
Serious events: 5 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Naproxen
n=257 participants at risk
Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days.
|
Placebo
n=253 participants at risk
Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days.
|
|---|---|---|
|
General disorders
Death
|
1.9%
5/257
|
1.2%
3/253
|
Other adverse events
| Measure |
Naproxen
n=257 participants at risk
Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
naproxen: Oral naproxen twice daily for 5-8 days.
|
Placebo
n=253 participants at risk
Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
placebo: Oral placebo twice daily for 5-8 days.
|
|---|---|---|
|
Cardiac disorders
Supraventricular tachycardia (SVT); Rash
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Infections and infestations
Infection - right breast w/ cellulitis, normal ANC
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Endocrine disorders
Hyperglycemia
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Immune system disorders
Anaphylactic reaction
|
0.39%
1/257 • Number of events 1
|
0.00%
0/253
|
|
Musculoskeletal and connective tissue disorders
Acute pain secondary to marrow expansion
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Gastrointestinal disorders
Hospitalized d/t NV, Diarrhea
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
|
Infections and infestations
Neutropenic fever
|
0.00%
0/257
|
0.40%
1/253 • Number of events 1
|
Additional Information
Charles E. Heckler, PhD, MS. Research Assistant Professor
University of Rochester Medical Center
Phone: 585-273-1141
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place