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NCT00489411 · ClinicalTrials.gov registry record · Phase 3
Duloxetine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
A Phase 3 study of Pain and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 231
- Enrollment target
- 20
- Study locations
NCT00489411: Completed Phase 3 study of Pain and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Alliance for Clinical Trials in Oncology.
NCT00489411 is a Phase 3 study of Pain and Unspecified Adult Solid Tumor, Protocol Specific that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 231 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (24% lower). The trial reports 20 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00489411, a Phase 3 study of Pain and Unspecified Adult Solid Tumor, Protocol Specific, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 231 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Change in average pain from Week 1 to Week 5, measured on day 1 of Weeks 1 and 6 by the Brief Pain Inventory Short Form (BPI-SF) was calculated as value at Day 1 of Week 1 minus value at Day 1 of Week 6 to yield positive improvement values. The BPI-SF contains 4 items assessing average, worst, least, and intermediate pain severity in the last 24 hours. Pain severity items are scored using an 11-point numeric rating scale (0, no pain; 10, pain as bad as you can imagine). Average pain severity was
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 231 participants |
| Start Date | 2008-04 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT00489411 record still lists
NCT00489411 is an interventional study that assigns participants to a tested intervention. The registered 231 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (24% lower).
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.
NCT00489411 names 20 study sites across 1 states, led by California.
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.
What interventions are being tested in trial NCT00489411?
The interventions under investigation include: placebo (OTHER), duloxetine hydrochloride (DRUG).
Who is sponsoring clinical trial NCT00489411?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT00489411's enrollment target sits among peer trials
231 79th of 374 higher than 296 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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