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NCT00516503 · ClinicalTrials.gov registry record · Phase 3

Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.

Completed
Registry status
Phase 3
Development phase
208
Enrollment target

NCT00516503 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 208 participants.

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The verdict

NCT00516503, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.

COMPLETED
Registry status
Phase 3
Development phase
208 participants
Enrollment target

Study Summary

RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy . PURPOSE: This randomized phase III trial is studying BAK gel 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 baclofen/amitriptyline/ketamine gel

Trial Details

FieldValue
Enrollment Target 208 participants
Start Date 2008-02
Est. Completion 2010-01
Phase Phase 3

What the Registry Record Tells You About NCT00516503

The ClinicalTrials.gov registry entry for NCT00516503 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 208 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 446 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.

NCT00516503 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00516503 about?

NCT00516503 is a clinical study titled "Baclofen-Amitriptyline Hydrochloride-Ketamine Gel in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer". RATIONALE: Baclofen-amitriptyline-ketamine (BAK) gel may lessen peripheral neuropathy caused by chemotherapy. It is not yet known whether BAK gel is more effective than a placebo in treating peripheral neuropathy caused by chemotherapy . PURPOSE: This randomized phase III trial is studying BAK gel ...

What is the current status of trial NCT00516503?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 208 participants. The study started on 2008-02. Estimated completion is 2010-01.

What interventions are being tested in trial NCT00516503?

The interventions under investigation include: placebo (OTHER), baclofen/amitriptyline/ketamine gel (DRUG).

Who is sponsoring clinical trial NCT00516503?

This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.