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

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01914042
• Other study ID #: 143-10 RMB
• Status: Recruiting
• Phase: Phase 2
• Start date: July 2013
• Est. completion date: December 2019

Study information

• Verified date: April 2019
• Source: Rambam Health Care Campus
• Contact: Elon Eisenberg, MD
• Phone: 972 4 8542880
• Email: e_eisenberg[@]rambam.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain

Intervention

Drug:
• Morphine

• Milnacipran

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuropathic pain intensity (NPS)		1 month
Secondary	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
Secondary	The McGill Pain Questionnaire	Will be completed before and after treatment	At baseline and at the end of 4-week treatment period
Secondary	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.