Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica
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|ClinicalTrials.gov Identifier: NCT01914042|
Recruitment Status : Recruiting
First Posted : August 1, 2013
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neuropathic Pain||Drug: Morphine Drug: Milnacipran||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Prediction of Inter-individual Differences in the Response to Morphine by Psychophysical Assessment of Pain Enhancing and Inhibiting Mechanisms in Patients With Chronic Neuropathic Pain|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||December 2019|
Morphine in changing dosages (range between 10-60 mg twice a day). Opioid titration proceeds as follows: starting at an oral dose of 10 mg twice per day, followed every 5 days by a dose increase of 10 mg twice per day until (1) adequate analgesia had been achieved (as determined by the patients), (2) side effects (severe sedation, nausea or vomiting, constipation, sleep disturbances) limited further titration, or (3) a total of 120 mg per day had been reached.
Active Comparator: Milnacipran
Milnacipran (Ixel)- a serotonin-norepinephrine reuptake inhibitor (SNRI), will be administrated in changing dosages (range between 12.5-75 mg twice daily). SNRI titration proceeds as follows: starting at an oral dose of 12.5 mg twice per day, followed every 5 days by a dose increase of 12.5 mg twice per day until (1) adequate analgesia had been achieved (as determined by the patients), (2) side effects (severe sedation, nausea or vomiting, constipation, sleep disturbances) limited further titration, or (3) a total of 150 mg per day had been reached.
- Neuropathic pain intensity (NPS) [ Time Frame: 1 month ]
- Heat pain intensity in a remote area (Opioid induced hyperalgesia) [ Time Frame: 1 month ]Heat pain sensitivity will be determined by the use of VAS units (0-100). We'll measure the intensity of pain in response to application of brief experimental heat pain.
- The McGill Pain Questionnaire [ Time Frame: At baseline and at the end of 4-week treatment period ]Will be completed before and after treatment
- Assessment of Adverse events [ Time Frame: Ongoing throughout the entire study period, an expected average of 4 weeks. ]
A list of possible side effects from the administered drugs has been prepared and will be completed at all scheduled visits.
In addition, patients will record AEs on daily basis. If needed patients can call and report adverse events by phone.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01914042
|Contact: Elon Eisenberg, MD||972 4 firstname.lastname@example.org|
|Rambam Health Care Campus||Recruiting|
|Haifa, Israel, 31096|
|Contact: Elon Eisenberg, MD 972 4 8542880 email@example.com|
|Principal Investigator: Elon Eisenberg, MD|