Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica

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

Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.

Study Overview

• Status: Unknown
• Conditions: Neuropathic Pain
• Intervention / Treatment: Drug: Morphine; Drug: Milnacipran

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • Recruiting
    • Rambam Health Care Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients with moderate to severe chronic neuropathic pain or patients with radiculitis between 18 and 75 years of age.
2. Candidates for chronic opioid therapy for nonmalignant pain as determined by treating physician.
3. Patients treated with non-opioid analgetics, anti- inflammatory drugs or low opioid dosage (< 30 mg of oral morphine-equivalents per day).

4. 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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Morphine; 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.	Drug: Morphine
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.	Drug: Milnacipran

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neuropathic pain intensity (NPS)	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month
The McGill Pain Questionnaire	Will be completed before and after treatment	At baseline and at the end of 4-week treatment period
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.	Ongoing throughout the entire study period, an expected average of 4 weeks.

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: July 22, 2013
• First Submitted That Met QC Criteria: July 30, 2013
• First Posted (Estimate): August 1, 2013

Study Record Updates

• Last Update Posted (Actual): April 2, 2019
• Last Update Submitted That Met QC Criteria: April 1, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Sciatica; Neuropathic pain; Opioid induced hyperalgesia; Opioids; Serotonin-norepinephrine reuptake inhibitor (SNRI)
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics, Opioid; Narcotics; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Morphine; Milnacipran; Levomilnacipran
• Other Study ID Numbers: 143-10 RMB