Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy

• Sponsor: NEMA Research, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00380965
• Collaborator: (none)
• Enrollment: 23
• Locations: 2
• Duration (Months): 12
• Patients Per Site: 11.5
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Neuropathy; Antineoplastic Combined Chemotherapy Protocols	Drug: Cesamet™ (nabilone)	Phase 4

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 23 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter Trial Evaluating the Safety and Efficacy of Cesamet™ for the Symptomatic Treatment of Chemotherapy-Induced Neuropathic Pain in Patients With Cancer
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Oct 1, 2007
• Actual Study Completion Date: Oct 1, 2007

Outcome Measures

Primary Outcome Measures

1. The Average Pain Score at target site. []

Secondary Outcome Measures

1. The Worst Pain Score at target site. []

2. The Pain at Night Score at target site. []

3. Quality of Life measures. []

4. Patient satisfaction with treatment. []

5. Safety will be assessed through the collection of AEs and vital signs. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	South Florida Medical Research	Aventura	Florida	United States	33180
2	Naples Anesthesia and Pain Associates	Naples	Florida	United States	34108

Sponsors and Collaborators

• NEMA Research, Inc.

Investigators

• Principal Investigator: Joseph V Pergolizzi, MD, NEMA Research, Inc.
• Study Director: Charlotte A Richmond, PhD, NEMA Research, Inc.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Nema Research website

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00380965
• Other Study ID Numbers: CB1 Study 003
• First Posted: Sep 27, 2006
• Last Update Posted: Feb 15, 2008
• Last Verified: Feb 1, 2008

• Keywords provided by , ,: Chemotherapy-induced; neuropathy; cancer
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Nabilone

Study Results

No Results Posted as of Feb 15, 2008