Status:
COMPLETED
Sativex for Treatment of Chemotherapy Induced Neuropathic Pain
Lead Sponsor:
Mary Lynch
Conditions:
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Chemotherapy is often used to treat cancer and in many cases can cure it or extend life. Unfortunately many of the chemotherapeutic agents used in treating cancer can cause nerve damage, resulting in ...
Detailed Description
The problem of neuropathic pain: A recent review has identified a neuropathic pain prevalence rate of 2-3% in the general population 1. Based on a Canadian population of 30 million, this means that c...
Eligibility Criteria
Inclusion
- Age \>18 years
- Neuropathic pain beginning after chemotherapy with paclitaxil, vincristine or cis-platin that has been present for 3 months or longer.
- Presence of allodynia, hyperalgesia or hypoesthesia on sensory testing in the area of pain.
- Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
- Medications must have been stable for at least14 days.
- Ability to follow the protocol
- Willing and able to give written informed consent.
Exclusion
- Ischemic heart disease
- Personal history of schizophrenia or psychotic disorder
- Family history of schizophrenia or psychotic disorder in first degree family member (parent, sibling or child)
- Allergy to cannabinoids
- Presence of any other clinically significant medical disorder (other than the cancer requiring chemotherapy) on history or physical exam that would compromise the participants' safety in the trial as judged by the study physician
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00872144
Start Date
June 1 2010
End Date
March 1 2013
Last Update
March 7 2014
Active Locations (1)
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1
Queen Elizabeth II Health Sciences Centre, Pain Management Unit
Halifax, Nova Scotia, Canada, B3H 2Y9