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

NCT ID: NCT01914042

Last Updated: 2019-04-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2019-12-31

Brief Summary

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

Conditions

Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Morphine

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Milnacipran

Intervention Type: DRUG

Interventions

Morphine

Intervention Type: DRUG

Milnacipran

Intervention Type: DRUG

Eligibility 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Eisenberg Elon MD

Director, Pain Research Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rambam Health Care Campus

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Elon Eisenberg, MD

Role: CONTACT

e_eisenberg@rambam.health.gov.il

972 4 8542880

Facility Contacts

Elon Eisenberg, MD

Role: primary

e_eisenberg@rambam.health.gov.il

972 4 8542880

Other Identifiers

143-10 RMB

Identifier Type: -

Identifier Source: org_study_id