Evaluation of the Efficacy of Cesamet™ for the Treatment... | NCT00380965

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2006

Primary Completion Date

Oct 2007Actual

Completion Date

Oct 2007Actual

First Submitted Date

Sep 25, 2006

First Submission Date that Met QC Criteria

Sep 25, 2006

First Posted Date

Sep 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2008

Last Update Posted Date

Feb 15, 2008Estimated

Description Module

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.

Detailed Description

To determine the safety and efficacy of Cesamet™ in the symptomatic treatment of chemotherapy-induced neuropathic pain.

This is a phase IV, multicenter, open label of Cesamet™ at 1 mg daily progressing to 2mg BID in subjects with chemotherapy-induced neuropathic pain. This study has two phases: A pretreatment phase and a treatment phase.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Estimated

Name	Type	Description	Arm Group Labels	Other Names
Cesamet™ (nabilone)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Average Pain Score at target site.

Secondary Outcomes

Measure	Description	Time Frame
The Worst Pain Score at target site.
The Pain at Night Score at target site.
Quality of Life measures.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph V Pergolizzi, MD	NEMA Research, Inc.	Principal Investigator
Charlotte A Richmond, PhD	NEMA Research, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
South Florida Medical Research		Aventura	Florida	33180	United States
Naples Anesthesia and Pain Associates

Label	URL
Nema Research website	View source

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D010523	Peripheral Nervous System Diseases
D009369	Neoplasms

ID	Term
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases