Trial · NCT01712009
NOLAN: Naproxen or Loratadine and Neulasta
NCT01712009, Phase 2, Completed, Amgen; results first posted 2016-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. NOLAN: Naproxen or Loratadine and Neulasta. Trials, record NCT01712009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01712009
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NOLAN: Naproxen or Loratadine and Neulasta
- NCT number
- NCT01712009
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 600 participants, actual
- Lead sponsor
- Amgen
- Conditions
- Bone Pain in Stage I - III Breast Cancer
- Interventions
- Naproxen, Loratadine, Pegfilgrastim, Chemotherapy
- First posted
- 2012-10-23
- Last updated
- 2018-01-30
- Results first posted
- 2016-03-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Bone Pain (All Grades) in Cycle 1 | Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval) | Bone pain data were captured as part of standard adverse event (AE) reporting. |
| Secondary | Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles | Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval) | Bone pain data were captured as part of standard adverse event (AE) reporting. |
| Secondary | Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles | Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval) | Bone pain data were captured as part of standard adverse event reporting. Severe bone pain is defined as grade 3 or 4 according to common terminology criteria for adverse events (CTCAE) version 3 grading criteria: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening or disabling. |
| Secondary | Mean Patient-reported Bone Pain by Cycle and Across Cycles | Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle) | Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Mean patient-reported bone pain values are the average of each participant's bone pain values across survey days 1-5 within each cycle. Across all cycles the mean is the average of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An analysis of variance (ANOVA) model with treatment as explanatory term was used. |
| Secondary | Maximum Patient-reported Bone Pain by Cycle and Across Cycles | Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle) | Participants completed a brief bone pain survey once per day for 5 days beginning the day they received their pegfilgrastim injection. The bone pain survey collected the severity of pain using a 0 (no pain) to 10 (worst pain) scale. Maximum patient-reported bone pain is the maximum of each participant's bone pain values across survey Days 1-5 within each cycle. Across all cycles the maximum is the maximum of each patient-reported bone pain value across all survey days 1-5 and across all cycles. An ANOVA model with treatment as explanatory term was used. |
| Secondary | Area Under the Curve (AUC) for Patient-reported Bone Pain | Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle) | Patient-reported bone pain AUC was calculated using the trapezoidal rule with bone pain scores from day 1 to 5 for each cycle. The AUC across cycles is the average of AUCs across the cycle. |
| Secondary | Number of Participants With Adverse Events (AEs) | From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks. | Severity was graded using CTCAE version 3. A serious adverse event (SAE) is defined as an adverse event that meets at least 1 of the following serious criteria: • fatal; • life threatening; • requires in-patient hospitalization or prolongation of existing hospitalization; • results in persistent or significant disability/incapacity; • congenital anomaly/birth defect; • other medically important serious event. The investigator assessed each adverse event for relatedness to investigational product(s) or other protocol-required therapies. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Bone Pain (All Grades) in Cycle 1 | Cycle 1 (approximately 4 weeks, depending on the chemotherapy dosing interval) | Full anlysis set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles | Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval) | Full analysis set; n indicates the number of participants who entered each cycle. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Severe Bone Pain by Cycle and Across Cycles | Cycles 1, 2, 3 and 4 (approximately 4 weeks each, depending on the chemotherapy dosing interval) | Full analysis set; n indicates the number of participants who entered each cycle. | percentage of participants | NUMBER |
| SECONDARY | Mean Patient-reported Bone Pain by Cycle and Across Cycles | Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle) | Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Maximum Patient-reported Bone Pain by Cycle and Across Cycles | Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle) | Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Area Under the Curve (AUC) for Patient-reported Bone Pain | Five consecutive days during each cycle beginning on the day of pegfilgrastim administration (Day 2, 3, or 4 of each cycle) | Full analysis set; all missing values of patient-reported bone pain within any cycle were imputed. n indicates the number of participants who entered each cycle. | units on a scale * days | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From first dose of investigational product (IP, naproxen or loratidine) or first dose of pegfilgrastim (Peg), whichever occurred first, until 30 days after last dose, up to 24 weeks. | Safety analysis set included all participants who received primary prophylaxis with pegfilgrastim according to the prophylactic medication actually received. Participants in the Naproxen or Loratadine groups who did not receive naproxen or loratadine are analyzed in the No Prophylaxis group for safety analyses. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group123
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Bone Pain (All Grades) in Cycle 1 | No Prophylaxis | 46.6 | 95% Confidence Interval 39.4 to 53.9 | percentage of participants | |
| Percentage of Participants With Bone Pain (All Grades) in Cycle 1 | Naproxen 500 mg BID | 40.3 | 95% Confidence Interval 33.4 to 47.5 | percentage of participants | |
| Percentage of Participants With Bone Pain (All Grades) in Cycle 1 | Loratadine 10 mg QD | 42.5 | 95% Confidence Interval 35.6 to 49.7 | percentage of participants | |
| Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles | No Prophylaxis | Cycle 2 (n=178, 180, 193) | 34.3 | 95% Confidence Interval 27.3 to 41.7 | percentage of participants |
| Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles | Naproxen 500 mg BID | Cycle 2 (n=178, 180, 193) | 34.4 | 95% Confidence Interval 27.5 to 41.9 | percentage of participants |
| Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles | Loratadine 10 mg QD | Cycle 2 (n=178, 180, 193) | 34.7 | 95% Confidence Interval 28.0 to 41.9 | percentage of participants |
| Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles | No Prophylaxis | Cycle 3 (n=165, 176, 188) | 33.9 | 95% Confidence Interval 26.8 to 41.7 | percentage of participants |
| Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles | Naproxen 500 mg BID | Cycle 3 (n=165, 176, 188) | 34.1 | 95% Confidence Interval 27.1 to 41.6 | percentage of participants |
| Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles | Loratadine 10 mg QD | Cycle 3 (n=165, 176, 188) | 36.2 | 95% Confidence Interval 29.3 to 43.5 | percentage of participants |
| Percentage of Participants With Bone Pain (All Grades) by Cycle (2-4) and Across Cycles | No Prophylaxis | Cycle 4 (n=162, 169, 179) | 40.7 | 95% Confidence Interval 33.1 to 48.7 | percentage of participants |
1 to 10 of 123Source ClinicalTrials.gov
See all 123 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | No Prophylaxis | 198 | |
| Overall Study | STARTED | Naproxen 500 mg BID | 200 | |
| Overall Study | STARTED | Loratadine 10 mg QD | 202 | |
| Overall Study | Received Pegfilgrastim | No Prophylaxis | 191 | |
| Overall Study | Received Pegfilgrastim | Naproxen 500 mg BID | 196 | |
| Overall Study | Received Pegfilgrastim | Loratadine 10 mg QD | 200 | |
| Overall Study | Received Naproxen / Loratadine | No Prophylaxis | 0 | |
| Overall Study | Received Naproxen / Loratadine | Naproxen 500 mg BID | 193 | |
| Overall Study | Received Naproxen / Loratadine | Loratadine 10 mg QD | 198 | |
| Overall Study | COMPLETED | No Prophylaxis | 160 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events360
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 | Anaemia | Blood and lymphatic system disorders | No Prophylactic Intervention | 42 | 196 | |
| other | Anaemia | Blood and lymphatic system disorders | Naproxen 500mg BID | 60 | 193 | |
| other | Anaemia | Blood and lymphatic system disorders | Loratadine 10mg QD | 40 | 198 | |
| other | Leukopenia | Blood and lymphatic system disorders | No Prophylactic Intervention | 10 | 196 | |
| other | Leukopenia | Blood and lymphatic system disorders | Naproxen 500mg BID | 10 | 193 | |
| other | Leukopenia | Blood and lymphatic system disorders | Loratadine 10mg QD | 7 | 198 | |
| other | Lymphopenia | Blood and lymphatic system disorders | No Prophylactic Intervention | 2 | 196 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Naproxen 500mg BID | 10 | 193 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Loratadine 10mg QD | 2 | 198 | |
| other | Neutropenia | Blood and lymphatic system disorders | No Prophylactic Intervention | 19 | 196 |
1 to 10 of 360Source ClinicalTrials.gov
See all 360 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | No Prophylactic Intervention | ||
| Total, all-cause mortality | Naproxen 500mg BID | ||
| Total, all-cause mortality | Loratadine 10mg QD | ||
| Total, other adverse events | No Prophylactic Intervention | 184 | 196 |
| Total, other adverse events | Naproxen 500mg BID | 190 | 193 |
| Total, other adverse events | Loratadine 10mg QD | 193 | 198 |
| Total, serious adverse events | No Prophylactic Intervention | 34 | 196 |
| Total, serious adverse events | Naproxen 500mg BID | 30 | 193 |
| Total, serious adverse events | Loratadine 10mg QD | 14 | 198 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29147854 | BACKGROUND |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01712009
GET https://conductscience.org/api/trials/v1/NCT01712009/results?page=2