Peripheral NeuropathyPhase 4NCT00380965
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Chemotherapy-Induced Neuropathy
A Phase 4 study testing Cesamet™ (nabilone) in people with Peripheral Neuropathy and Antineoplastic Combined Chemotherapy Protocols, run by NEMA Research, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peripheral Neuropathy, Antineoplastic Combined Chemotherapy Protocols
- What is being tested?
- Cesamet™ (nabilone)
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hypersensitivity to compounds in study drug or similar drugs
- Pregnant or lactating females
- Drug or alcohol abuse
- Unstable medical condition
Trial locations and contacts
2 sites in 1 country.
United States2 sites
South Florida Medical Research
Aventura, Florida, 33180
Naples Anesthesia and Pain Associates
Naples, Florida, 34108
About this study
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
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.
Read the 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.
- Being tested
- Cesamet™ (nabilone)
- Keywords
- Chemotherapy-induced, neuropathy, cancer
- Medical subject headings
- Peripheral Nervous System Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesamet™ (nabilone)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NEMA Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Joseph V Pergolizzi, MD, Principal investigator, NEMA Research, Inc.Charlotte A Richmond, PhD, Study director, NEMA Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380965
- Sponsor's protocol ID
- CB1 Study 003
- Status last verified
- Feb 2008
- First submitted
- 25 Sep 2006
- Last updated
- 15 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00380965
- Acronym / sponsor ID
- CB1 Study 003
- Keywords
- Chemotherapy-induced, neuropathy, cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- NEMA Research, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Hypersensitivity to compounds in study drug or similar drugs
- Pregnant or lactating females
- Drug or alcohol abuse
- Unstable medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesamet™ (nabilone) | Drug | – |
Primary outcome
The Average Pain Score at target site.
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2008.
- Nema Research websiteLink provided by the sponsor.
Related trials for Peripheral Neuropathy
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Active, not recruiting
The AIUR Trial: Surgical Gloves to Prevent Peripheral Neuropathy
Chemotherapy-induced Peripheral Neuropathy
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph V Pergolizzi, MD principal investigator
NEMA Research, Inc.
Charlotte A Richmond, PhD study director
NEMA Research, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cesamet™ (nabilone) in people with Peripheral Neuropathy and Antineoplastic Combined Chemotherapy Protocols, run by NEMA Research, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Average Pain Score at target site.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2008.