Back to resultsPrediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica
Primary Purpose
Neuropathic Pain
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Morphine
Milnacipran
Sponsored by
About this trial
This is an interventional treatment trial for Neuropathic Pain focused on measuring Opioid induced hyperalgesia, Neuropathic pain, Opioids, Sciatica, Serotonin-norepinephrine reuptake inhibitor (SNRI)
Eligibility Criteria
Inclusion Criteria:
- Patients with moderate to severe chronic neuropathic pain or patients with radiculitis between 18 and 75 years of age.
- Candidates for chronic opioid therapy for nonmalignant pain as determined by treating physician.
- Patients treated with non-opioid analgetics, anti- inflammatory drugs or low opioid dosage (< 30 mg of oral morphine-equivalents per day).
Ability to understand the purpose and instructions of the study and to sign an informed consent.
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Exclusion Criteria:
1.Diabetic Neuropathy 2.Pain in upper limbs 3.Receiving anti- depressants and/or anticonvulsants 4.Pregnant women 5.Inability to comply with study protocol. 6.Allergy to Opioids 7.A diagnosis of Raynaud's Syndrome 8.History of substance abuse
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Sites / Locations
- Rambam Health Care CampusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Morphine
Milnacipran
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Neuropathic pain intensity (NPS)
Secondary Outcome Measures
Heat pain intensity in a remote area (Opioid induced hyperalgesia)
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
Will be completed before and after treatment
Assessment of Adverse events
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01914042
Brief Title
Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica
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 Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Opioid induced hyperalgesia, Neuropathic pain, Opioids, Sciatica, Serotonin-norepinephrine reuptake inhibitor (SNRI)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morphine
Arm Type
Experimental
Arm Description
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.
Arm Title
Milnacipran
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Type
Drug
Intervention Name(s)
Milnacipran
Primary Outcome Measure Information:
Title
Neuropathic pain intensity (NPS)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Heat pain intensity in a remote area (Opioid induced hyperalgesia)
Description
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.
Time Frame
1 month
Title
The McGill Pain Questionnaire
Description
Will be completed before and after treatment
Time Frame
At baseline and at the end of 4-week treatment period
Title
Assessment of Adverse events
Description
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.
Time Frame
Ongoing throughout the entire study period, an expected average of 4 weeks.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with moderate to severe chronic neuropathic pain or patients with radiculitis between 18 and 75 years of age.
Candidates for chronic opioid therapy for nonmalignant pain as determined by treating physician.
Patients treated with non-opioid analgetics, anti- inflammatory drugs or low opioid dosage (< 30 mg of oral morphine-equivalents per day).
Ability to understand the purpose and instructions of the study and to sign an informed consent.
-
Exclusion Criteria:
1.Diabetic Neuropathy 2.Pain in upper limbs 3.Receiving anti- depressants and/or anticonvulsants 4.Pregnant women 5.Inability to comply with study protocol. 6.Allergy to Opioids 7.A diagnosis of Raynaud's Syndrome 8.History of substance abuse
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elon Eisenberg, MD
Phone
972 4 8542880
Email
e_eisenberg@rambam.health.gov.il
Facility Information:
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elon Eisenberg, MD
Phone
972 4 8542880
Email
e_eisenberg@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Elon Eisenberg, MD
12. IPD Sharing Statement
Learn more about this trial
Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica
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