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COMPLETED Phase 3

Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

NCT00489411 · View on ClinicalTrials.gov ↗

Study Summary

RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works compared with a placebo in treating peripheral neuropathy caused by chemotherapy in patients with cancer.

Interventions

  • OTHER placebo
  • DRUG duloxetine hydrochloride

Study Locations (20)

California

  • Kaiser Permanente - Deer Valley — Antioch
  • Alta Bates Summit Comprehensive Cancer Center — Berkeley
  • Peninsula Medical Center — Burlingame
  • East Bay Radiation Oncology Center — Castro Valley
  • Valley Medical Oncology Consultants - Castro Valley — Castro Valley
  • Cancer Care Center at John Muir Health - Concord Campus — Concord
  • Kaiser Permanente - Fremont — Fremont
  • Valley Medical Oncology — Fremont
  • Glendale Memorial Hospital Comprehensive Cancer Center — Glendale
  • Kaiser Permanente Medical Center - Hayward — Hayward
  • Rebecca and John Moores UCSD Cancer Center — La Jolla
  • USC/Norris Comprehensive Cancer Center and Hospital — Los Angeles
  • Contra Costa Regional Medical Center — Martinez
  • Camino Medical Group - Treatment Center — Mountain View
  • El Camino Hospital Cancer Center — Mountain View
  • Highland General Hospital — Oakland
  • Alta Bates Summit Medical Center - Summit Campus — Oakland
  • Bay Area Breast Surgeons, Incorporated — Oakland
  • CCOP - Bay Area Tumor Institute — Oakland
  • Larry G Strieff MD Medical Corporation — Oakland

Trial Details

FieldValue
Enrollment Target 231 participants
Start Date 2008-04
Est. Completion 2013-03
Phase Phase 3

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00489411

The ClinicalTrials.gov registry entry for NCT00489411 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 231 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alliance for Clinical Trials in Oncology, which has 147 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions — of which placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00489411 reports 20 study locations spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT00489411 about?

NCT00489411 is a clinical study titled "Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer". RATIONALE: Duloxetine may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether duloxetine is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying duloxetine to see how well it works c...

What is the current status of trial NCT00489411?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 231 participants. The study started on 2008-04. Estimated completion is 2013-03.

What conditions does trial NCT00489411 study?

This clinical trial studies the following conditions: Pain, Unspecified Adult Solid Tumor, Protocol Specific, Peripheral Neuropathy, Neurotoxicity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00489411?

The interventions under investigation include: placebo (OTHER), duloxetine hydrochloride (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00489411?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 147 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00489411 being conducted?

This trial has 20 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial