Neuropathic PainPhase 2NCT01914042
Prediction of Inter-individual Differences in the Response to Morphine Versus Milnacipran in Patients With Sciatica
A Phase 2 study testing Morphine and Milnacipran in people with Neuropathic Pain, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Morphine and Milnacipran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2013to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 31096
Elon Eisenberg, MD, 972 4 8542880, e_eisenberg@rambam.health.gov.il
Elon Eisenberg, MD
About this study
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, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.
- Conditions
- Neuropathic Pain
- Being tested
- Morphine, Milnacipran
- Keywords
- Opioid induced hyperalgesia, Neuropathic pain, Opioids, Sciatica, Serotonin-norepinephrine reuptake inhibitor (SNRI)
- Medical subject headings
- Neuralgia, Sciatica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
MilnacipranDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Milnacipran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropathic pain intensity (NPS)
Measured: 1 month
Secondary outcomes (3)
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.
Measured: 1 month
The McGill Pain Questionnaire
Will be completed before and after treatment
Measured: At baseline and at the end of 4-week treatment period
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.
Measured: Ongoing throughout the entire study period, an expected average of 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJul 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eisenberg Elon MD, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01914042
- Sponsor's protocol ID
- 143-10 RMB
- Status last verified
- Apr 2019
- First submitted
- 22 Jul 2013
- Last updated
- 2 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01914042
- Acronym / sponsor ID
- 143-10 RMB
- Conditions
- Neuropathic Pain
- Keywords
- Opioid induced hyperalgesia, Neuropathic pain, Opioids, Sciatica, Serotonin-norepinephrine reuptake inhibitor (SNRI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical, psychophysical, behavioral or genetic factor will predict the response to opioid treatment in patients with chronic neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Morphine | Experimental | Drug: MorphineMorphine 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. |
| Milnacipran | Active comparator | Drug: MilnacipranMilnacipran (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine | Drug | Morphine |
| Milnacipran | Drug | Milnacipran |
Primary outcome
Neuropathic pain intensity (NPS)
Time frame: 1 month
3 secondary outcomes
Heat pain intensity in a remote area (Opioid induced hyperalgesia)
Time frame: 1 month
The McGill Pain Questionnaire
Time frame: At baseline and at the end of 4-week treatment period
Assessment of Adverse events
Time frame: Ongoing throughout the entire study period, an expected average of 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
Related trials for Neuropathic Pain
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Hand Pain in Rheumatoid Arthritis
Rheumatoid Arthritis
RecruitingPhase 2
A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Diabetic Peripheral Neuropathic Pain
Diabetic Peripheral Neuropathic Pain
Not yet recruitingObservational study
SERENITY Study of Chronic Pain Interference in Adults
Chronic Low Back Pain, Spinal Cord Injury
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Morphine and Milnacipran in people with Neuropathic Pain, run by Rambam Health Care Campus at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elon Eisenberg, MD (972 4 8542880, e_eisenberg@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropathic pain intensity (NPS) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019.