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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Eisenberg Elon MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01914042
First received: July 22, 2013
Last updated: September 14, 2016
Last verified: September 2016
  Purpose
Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.

Condition Intervention Phase
Neuropathic Pain
Drug: Morphine
Drug: Milnacipran
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • Neuropathic pain intensity (NPS) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Heat pain intensity in a remote area (Opioid induced hyperalgesia) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 150
Study Start Date: July 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

    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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01914042

Contacts
Contact: Elon Eisenberg, MD 972 4 8542880 e_eisenberg@rambam.health.gov.il

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 31096
Contact: Elon Eisenberg, MD    972 4 8542880    e_eisenberg@rambam.health.gov.il   
Principal Investigator: Elon Eisenberg, MD         
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

Responsible Party: Eisenberg Elon MD, Director, Pain Research Unit, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01914042     History of Changes
Other Study ID Numbers: 143-10 RMB 
Study First Received: July 22, 2013
Last Updated: September 14, 2016
Health Authority: Israel: Ministry of Health

Keywords provided by Rambam Health Care Campus:
Opioid induced hyperalgesia
Neuropathic pain
Opioids
Sciatica
Serotonin-norepinephrine reuptake inhibitor (SNRI)

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Morphine
Norepinephrine
Milnacipran
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Autonomic Agents
Vasoconstrictor Agents
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators

ClinicalTrials.gov processed this record on December 06, 2016