EUCTR2007-002080-27-GB
Active, not recruiting
Not Applicable
A randomised, double-blind controlled trial of ketamine versus placebo in conjunction with best pain management in neuropathic pain in cancer patients - KPS
Greater Glasgow Health Board/University of Glasgow0 sites214 target enrollmentJune 27, 2008
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Greater Glasgow Health Board/University of Glasgow
- Enrollment
- 214
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\> 18 years of age
- •Patient has a histological proven cancer diagnosis
- •Written informed consent (to be obtained within 28 days prior to entry into the study)
- •Index neuropathic pain (as defined by LANSS) that is related to underlying malignancy or resulting from treatment received for this
- •Index neuropathic pain \>\= 4 on 0\-10 (VAS)
- •McGill Sensory Scale Score \> 5
- •Patient has had a trial of at least one adjuvant analgesic (gabapentin, pregabalin, amitriptyline) or has been offered these and declined
- •Patient is able to comply with study procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •Patients who have received chemotherapy or radiotherapy in the preceding six weeks that is likely to affect neuropathic pain
- •Patients who may have a change in tumoricidal treatment during the period of the study that is likely to alter pain during the course of the study
- •Diastolic blood pressure \> 100mmHg at screening
- •History of seizures in last 2 years
- •Patient is currently taking class I anti\-arrhythmic drugs
- •Life expectancy less than two months
- •Patients who are actively hallucinating
- •Women of childbearing potential who are not using adequate contraception
- •Patients with cerebrovascular disease (strokes)
- •Patients with psychotic disorders or cognitive impairment
Outcomes
Primary Outcomes
Not specified
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