duloxetine hydrochloride for Pain

Phase 3

Waitlist Available

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 of week 8 to day 1 of week 13

Awards & highlights

All Individual Drugs Already Approved

Pivotal Trial

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.

Eligible Conditions

Nerve Damage
Solid Tumors
Neurotoxicity
Pain

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 of week 8 to day 1 of week 13

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 of week 8 to day 1 of week 13

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 of week 8 to day 1 of week 13 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Average Pain From Week 1 to Week 5, as Measured by the BPI-SF Average Pain Severity Item

Secondary study objectives

Change in Average Pain From Week 8 to Week 12, as Measured by the BPI-SF Average Pain Severity Item

Change in Pain-related Functional Interference Score From Week 1 to Week 5, as Measured by the BPI-SF Interference Score

Change in the Total Score of the FACT/COG-NTX From Week 1 to Week 5

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II/Group B (Placebo then Duloxetine)Experimental Treatment2 Interventions

Patients receive an oral placebo once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive oral duloxetine hydrochloride once or twice daily in weeks 8-13.

Group II: Arm I/Group A (Duloxetine then Placebo)Experimental Treatment2 Interventions

Patients receive oral duloxetine hydrochloride once or twice daily in weeks 1-6. After a 1-week rest period, patients cross over to receive an oral placebo once or twice daily in weeks 8-13.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Duloxetine

FDA approved

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