Pain Clinical Trial
Official title:
Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial
Verified date | October 2015 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not
yet known whether naproxen is more effective than a placebo in preventing bone pain caused
by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.
PURPOSE: This randomized phase III trial is studying naproxen to see how well it works
compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with
non-hematologic cancer undergoing chemotherapy.
Status | Completed |
Enrollment | 510 |
Est. completion date | March 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 120 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of a non-hematologic (non-myeloid) malignancy - Scheduled to receive chemotherapy; chemotherapy may be given for adjuvant, neoadjuvant, curative, or palliative intent - Scheduled to receive the first dose of pegfilgrastim (Neulasta®) to ameliorate chemotherapy-induced neutropenia - Creatinine = 1.5 times upper limit of normal - Able to understand English - More than 6 months since prior surgery on the heart Exclusion Criteria: - Pregnant or nursing - Clinical evidence of active gastrointestinal bleeding, prior gastrointestinal bleeding, or gastric or duodenal ulcers - Allergy to naproxen - Prior development of the triad of asthma, rhinitis, and nasal polyps after taking acetylsalicylic acid (aspirin) or other NSAIDs - Concurrent nonsteroidal anti-inflammatory drugs (NSAIDs), such as aspirin, ibuprofen, or any product containing naproxen (e.g., Naprosyn, EC-Naprosyn, Anaprox, Anaprox-DS, Naprosyn suspension, or Aleve), on a regular basis - Concurrent steroids on a regular basis - Concurrent prescription or non-prescription medications for preexisting chronic pain; concurrent cardioprotective doses (= 325 mg/day) of aspirin allowed - Concurrent therapeutic doses of warfarin |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | CCOP - Columbus | Columbus | Ohio |
United States | CCOP - Dayton | Dayton | Ohio |
United States | CCOP - Central Illinois | Decatur | Illinois |
United States | CCOP - Evanston | Evanston | Illinois |
United States | CCOP - Southeast Cancer Control Consortium | Goldsboro | North Carolina |
United States | CCOP - Grand Rapids | Grand Rapids | Michigan |
United States | CCOP - Greenville | Greenville | South Carolina |
United States | MBCCOP - Hawaii | Honolulu | Hawaii |
United States | CCOP - Kansas City | Kansas City | Missouri |
United States | CCOP - Marshfield Clinic Research Foundation | Marshfield | Wisconsin |
United States | CCOP - Virginia Mason Research Center | Seattle | Washington |
United States | CCOP - Upstate Carolina | Spartanburg | South Carolina |
United States | CCOP - Metro-Minnesota | St. Louis Park | Minnesota |
United States | CCOP - Hematology-Oncology Associates of Central New York | Syracuse | New York |
United States | CCOP - Northwest | Tacoma | Washington |
United States | CCOP - Wichita | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Gary Morrow | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Area Under Curve (AUC) of Average Pain From Diary vs. Day (1-5), Calculated by the Trapezoidal Rule. | 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. | From baseline through day 5 | No |
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