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Completed Phase 2 Interventional Results available

NOLAN: Naproxen or Loratadine and Neulasta

ClinicalTrials.gov ID: NCT01712009

Public ClinicalTrials.gov record NCT01712009. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 9:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Randomized, Phase 2 Study to Estimate the Effect of Prophylactic Intervention With Naproxen or Loratadine on Bone Pain in Breast Cancer Subjects Receiving Chemotherapy and Pegfilgrastim

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of the study is to estimate the difference in bone pain between breast cancer patients receiving chemotherapy and pegfilgrastim and either no prophylactic intervention, prophylactic naproxen, or prophylactic loratadine.

Study identification

NCT ID
NCT01712009
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Amgen
Industry
Enrollment
600 participants

Conditions and interventions

Interventions

Drug · Biological

Eligibility (public fields only)

Age range
18 Years to 100 Years
Sex
Female
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 1, 2012 (Actual)
Primary completion
Mar 18, 2015 (Actual)
Completion
Mar 18, 2015 (Actual)
Last update posted
Jan 30, 2018

2012 – 2015

United States locations

U.S. sites
83
U.S. states
36
U.S. cities
81
Facility City State ZIP Site status
Research Site Muscle Shoals Alabama 35661 —
Research Site Anaheim California 92801 —
Research Site Fullerton California 92835 —
Research Site Santa Maria California 93454 —
Research Site Santa Rosa California 95403 —
Research Site Torrance California 90501 —
Research Site Whittier California 90603 —
Research Site Denver Colorado 80210 —
Research Site Golden Colorado 80401 —
Research Site Littleton Colorado 80122 —
Research Site Norwich Connecticut 06360 —
Research Site Stamford Connecticut 06902 —
Research Site Boynton Beach Florida 33426 —
Research Site Daytona Beach Florida 32114 —
Research Site Daytona Beach Florida 32117 —
Research Site Fort Lauderdale Florida 33308 —
Research Site Lakeland Florida 33805 —
Research Site New Port Richey Florida 34652 —
Research Site Plantation Florida 33324 —
Research Site Stuart Florida 34994 —
Research Site Augusta Georgia 30901 —
Research Site Thomasville Georgia 31792 —
Research Site Elmhurst Illinois 60126 —
Research Site Gurnee Illinois 60031 —
Research Site Mount Vernon Illinois 62864 —
Research Site Skokie Illinois 60076 —
Research Site Urbana Illinois 61801 —
Research Site Indianapolis Indiana 46237 —
Research Site South Bend Indiana 46601 —
Research Site Sioux City Iowa 51101 —
Research Site Waterloo Iowa 50702 —
Research Site Hutchinson Kansas 67502 —
Research Site Lexington Kentucky 40503 —
Research Site Louisville Kentucky 40202 —
Research Site Mount Sterling Kentucky 40353 —
Research Site Paducah Kentucky 42003 —
Research Site Alexandria Louisiana 71301 —
Research Site Lafayette Louisiana 70503 —
Research Site Marrero Louisiana 70072 —
Research Site Shreveport Louisiana 71103 —
Research Site Cumberland Maryland 21502 —
Research Site Randallstown Maryland 21133 —
Research Site Rockville Maryland 20850 —
Research Site Westminster Maryland 21157 —
Research Site Lowell Massachusetts 01854 —
Research Site Battle Creek Michigan 49017 —
Research Site Duluth Minnesota 55805 —
Research Site Saint Cloud Minnesota 56303 —
Research Site Jackson Mississippi 39202 —
Research Site Jefferson City Missouri 65101 —
Research Site Kansas City Missouri 64132 —
Research Site Saint Joseph Missouri 64507 —
Research Site St Louis Missouri 63136 —
Research Site Billings Montana 59101 —
Research Site Omaha Nebraska 68106 —
Research Site Nashua New Hampshire 03060 —
Research Site Denville New Jersey 07834 —
Research Site East Syracuse New York 13057 —
Research Site Johnson City New York 13790 —
Research Site Gastonia North Carolina 28054 —
Research Site Hickory North Carolina 28602 —
Research Site Pinehurst North Carolina 28374 —
Research Site Massillon Ohio 44646 —
Research Site Zanesville Ohio 43701 —
Research Site Bend Oregon 97701 —
Research Site Bethlehem Pennsylvania 18015 —
Research Site Langhorne Pennsylvania 19047 —
Research Site Florence South Carolina 29506 —
Research Site Watertown South Dakota 57201 —
Research Site Bristol Tennessee 37620 —
Research Site Chattanooga Tennessee 37421 —
Research Site Corpus Christi Texas 78404 —
Research Site Corpus Christi Texas 78412 —
Research Site Plano Texas 75093 —
Research Site Ogden Utah 84403 —
Research Site Chesapeake Virginia 23320 —
Research Site Spokane Washington 99208 —
Research Site Huntington West Virginia 25701 —
Research Site Janesville Wisconsin 53548 —
Research Site Madison Wisconsin 53792 —
Research Site Racine Wisconsin 53405 —
Research Site Wauwatosa Wisconsin 53226 —
Research Site Weston Wisconsin 54476 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01712009, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 30, 2018 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01712009 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →