Trial · NCT00602420
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
NCT00602420, Phase 3, Completed, Gary Morrow; results first posted 2015-05-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prevention of Pegfilgrastim-Induced Bone Pain (PIBP). Trials, record NCT00602420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00602420
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
- NCT number
- NCT00602420
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 510 participants, actual
- Lead sponsor
- Gary Morrow
- Conditions
- Musculoskeletal Complications, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- naproxen, placebo
- First posted
- 2008-01-28
- Last updated
- 2015-11-09
- Results first posted
- 2015-05-12
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. | From baseline through day 5 | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. | From baseline through day 5 | (Pain Scale Score)*Days | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. | Naproxen | 6.04 | 95% Confidence Interval 4.94 to 7.14 | (Pain Scale Score)*Days | |
| Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. | Placebo | 7.71 | 95% Confidence Interval 6.59 to 8.84 | (Pain Scale Score)*Days |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Naproxen | 257 | |
| Overall Study | STARTED | Placebo | 253 | |
| Overall Study | COMPLETED | Naproxen | 232 | |
| Overall Study | COMPLETED | Placebo | 229 | |
| Overall Study | NOT COMPLETED | Naproxen | 25 | |
| Overall Study | NOT COMPLETED | Placebo | 24 |
Source ClinicalTrials.gov
Adverse events16
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Supraventricular tachycardia (SVT); Rash | Cardiac disorders | Naproxen | 1 | 257 | 1 |
| other | Supraventricular tachycardia (SVT); Rash | Cardiac disorders | Placebo | 0 | 253 | 0 |
| other | Infection - right breast w/ cellulitis, normal ANC | Infections and infestations | Naproxen | 1 | 257 | 1 |
| other | Infection - right breast w/ cellulitis, normal ANC | Infections and infestations | Placebo | 0 | 253 | 0 |
| other | Hyperglycemia | Endocrine disorders | Naproxen | 1 | 257 | 1 |
| other | Hyperglycemia | Endocrine disorders | Placebo | 0 | 253 | 0 |
| other | Anaphylactic reaction | Immune system disorders | Naproxen | 1 | 257 | 1 |
| other | Anaphylactic reaction | Immune system disorders | Placebo | 0 | 253 | 0 |
| other | Acute pain secondary to marrow expansion | Musculoskeletal and connective tissue disorders | Naproxen | 0 | 257 | 0 |
| other | Acute pain secondary to marrow expansion | Musculoskeletal and connective tissue disorders | Placebo | 1 | 253 | 1 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Naproxen | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Naproxen | 4 | 257 |
| Total, other adverse events | Placebo | 3 | 253 |
| Total, serious adverse events | Naproxen | 5 | 257 |
| Total, serious adverse events | Placebo | 3 | 253 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10CA037420 | University of Rochester Cancer Center CCOP Research Base | MORROW, GARY R | UNIVERSITY OF ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 to 2014 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Naproxen vs Placebo: serious adverse events |
Source 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/NCT00602420
GET https://conductscience.org/api/trials/v1/NCT00602420/registered