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

Phase 2

• Conditions: Neuropathic Pain
• Interventions: Drug: Milnacipran; Drug: Morphine

• Registration Number: NCT01914042
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-22
• Study First Submitted QC: 2013-07-30
• Study First Posted: 2013-08-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02
• Primary Completion: 2019-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Milnacipran	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.
Morphine	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.

Primary Outcome Measures

Name	Time	Method
Neuropathic pain intensity (NPS)	1 month

Secondary Outcome Measures

Name	Time	Method
Heat pain intensity in a remote area (Opioid induced hyperalgesia)	1 month	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	At baseline and at the end of 4-week treatment period	Will be completed before and after treatment
Assessment of Adverse events	Ongoing throughout the entire study period, an expected average of 4 weeks.	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.

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel