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

NCT01914042 | Unknown Phase 2

• 1 other identifier: 143-10 RMB
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuropathic Pain

Keywords

Opioid induced hyperalgesia; Neuropathic pain; Opioids; Sciatica; Serotonin-norepinephrine reuptake inhibitor (SNRI)

Outcome Measures

Primary Outcomes (1)

• Neuropathic pain intensity (NPS)

  1 month

Secondary Outcomes (3)

• Heat pain intensity in a remote area (Opioid induced hyperalgesia)

  1 month

• The McGill Pain Questionnaire

  At baseline and at the end of 4-week treatment period

• Assessment of Adverse events

  Ongoing throughout the entire study period, an expected average of 4 weeks.

Study Arms (2)

Morphine

EXPERIMENTAL

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

Milnacipran

ACTIVE COMPARATOR

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

Interventions

Morphine DRUG

Morphine

Milnacipran DRUG

Milnacipran

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Health Care Campus

Haifa, 31096, Israel

RECRUITING

MeSH Terms

Conditions

Neuralgia; Sciatica

Interventions

Morphine; Milnacipran

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sciatic Neuropathy; Mononeuropathies

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Cyclopropanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Elon Eisenberg, MD

CONTACT

972 4 8542880; e_eisenberg@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Pain Research Unit

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: August 1, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 2, 2019

Record last verified: 2019-04

Locations

IL (1)