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Trial record 18 of 24 for:    nabilone OR cesamet

Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT00380913
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : February 15, 2008
Sponsor:
Information provided by:
NEMA Research, Inc.

Brief Summary:
This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.

Condition or disease Intervention/treatment Phase
Diabetic Neuropathies Drug: Cesamet™ (nabilone) Phase 4

Detailed Description:

The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to diabetic peripheral neuropathy.

This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a Pretreatment Phase and a Treatment Phase.


Study Type : Interventional  (Clinical Trial)
Estimated 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 Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
Study Start Date : September 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Nabilone




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.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with diabetic peripheral 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 visual analog scale

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380913


Locations
United States, Florida
South Florida Medical Research
Aventura, Florida, United States, 33180
Sunrise Clinical Research, Inc.
Hollywood, Florida, United States, 33021
Naples Anesthesia and Pain Associates
Naples, Florida, United States, 34108
Lazlo Mate, MD
West Palm Beach, Florida, United States, 33407
Sponsors and Collaborators
NEMA Research, Inc.
Investigators
Principal Investigator: Joseph V Pergolizzi, MD NEMA Research, Inc.
Study Director: Charlotte Richmond, PhD Nema Research

Additional Information:
Responsible Party: Joseph Pergolizzi, MD, NEMA Research
ClinicalTrials.gov Identifier: NCT00380913     History of Changes
Other Study ID Numbers: CB1 Study 001
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: February 15, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Nabilone
Peripheral Nervous System Diseases
Diabetic Neuropathies
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs