NCT00380965

Brief Summary

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to chemotherapy-induced neuropathic pain in patients with cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 27, 2006

Completed
4 days until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 15, 2008

Status Verified

February 1, 2008

Enrollment Period

1 year

First QC Date

September 25, 2006

Last Update Submit

February 14, 2008

Conditions

Peripheral NeuropathyAntineoplastic Combined Chemotherapy Protocols

Keywords

Chemotherapy-inducedneuropathycancer

Outcome Measures

Primary Outcomes (1)

  • The Average Pain Score at target site.

Secondary Outcomes (5)

  • The Worst Pain Score at target site.

  • The Pain at Night Score at target site.

  • Quality of Life measures.

  • Patient satisfaction with treatment.

  • Safety will be assessed through the collection of AEs and vital signs.

Interventions

Cesamet™ (nabilone)DRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with chemotherapy-induced neuropathic pain.
  • Chronic daily pain present for at least 2 months.
  • On stable analgesic regimen for one month.
  • Baseline pain score greater than 40mm on a VAS.

You may not qualify if:

  • Hypersensitivity to compounds in study drug or similar drugs
  • Pregnant or lactating females
  • Drug or alcohol abuse
  • Unstable medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

South Florida Medical Research

Aventura, Florida, 33180, United States

Location

Naples Anesthesia and Pain Associates

Naples, Florida, 34108, United States

Location

Related Links

MeSH Terms

Conditions

Peripheral Nervous System DiseasesNeoplasms

Interventions

nabilone

Condition Hierarchy (Ancestors)

Neuromuscular DiseasesNervous System Diseases

Study Officials

  • Joseph V Pergolizzi, MD

    NEMA Research, Inc.

    PRINCIPAL INVESTIGATOR

  • Charlotte A Richmond, PhD

    NEMA Research, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2006

First Posted

September 27, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

February 15, 2008

Record last verified: 2008-02

Locations

US(2)