Status:
COMPLETED
Efficacy & Safety Study of Nonracemic Methadone for the Relief of Chronic Peripheral Neuropathic Pain
Lead Sponsor:
MetaPharm, Inc.
Conditions:
Diabetic Peripheral Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There is a growing evidence that the d-isomer of methadone is effective in treating neuropathic pain while the l-isomer of methadone is the only effective isomer of methadone for treating somatic pain...
Detailed Description
Objectives: * To evaluate effect of the three doses of the non-racemic methadone HCl on the metrics of pain intensity in comparison to placebo. * To determine minimally effective and maximally tolera...
Eligibility Criteria
Inclusion
- Male or female 18 years of age or older;
- Female with a negative serum βhCG pregnancy test
- Female of non-childbearing potential (postmenopausal or surgically sterile) OR female of child-bearing potential agreed to use the protocol-approved contraceptive method
- Documented diagnosis of neuropathic pain associated with diabetic peripheral neuropathy for at least 6 months
- Average daily pain severity score \>=4 for the seven days prior to randomization (based on an 11-point numerical rating scale where 0= no pain and 10=worst possible pain)
- Score \>= 40 mm on the VAS of the Short Form McGill Pain Questionnaire (SF-MPQ) at screening and randomization visits
- Stable doses (for at least three weeks) of non-opioid analgesics including NSAIDS, corticosteroids, gabapentin, pregabalin or antidepressants prescribed for the purposes of pain control or pain treatment naïve
- Willing to refrain from any pain-relieving drugs other than the protocol-approved rescue medications (acetaminophen, \<= 3 g daily or aspirin \<= 325 mg daily) during the screening phase and the course of the study
- Willing to limit alcohol consumption during the study according to protocol requirements
- Able to understand and complete study diary and questionnaires
- Willing to give informed consent prior to entry into the study
Exclusion
- A documented neuropathy of any cause other than diabetic peripheral neuropathy
- A severe intermittent pain for reasons other than radiculopathy (e.g., migraine attacks)
- History of head injury and/or increased intracranial pressure
- Any neurologic disorder unrelated to diabetic peripheral neuropathy
- Non-adequate renal and/or hepatic function as follows: Serum creatinine \> 1.5 x ULN (upper limit of normal range) Liver enzymes (ALT and AST) \> 2 x ULN
- Any other know laboratory abnormality that, in the investigator's opinion, would contraindicate study participation
- Chronic hepatitis B, hepatitis C, or HIV infection
- Abnormal cognition defined as obvious clinical findings of state of arousal, confusion and memory or concentration deficit.
- Recent history (within the previous 12 months) of respiratory depression, acute bronchial asthma or hypercarbia, or any other severe pulmonary or respiratory disease
- Recent history (within the previous 12 months) of sleep apnea
- Any hemostatic disorders or a current treatment with anticoagulants;
- Unstable cardiovascular disease or symptomatic peripheral vascular disease
- Hypotension: sitting or standing systolic blood pressure \<= 90 mmHg and/or diastolic blood pressure \<= 60 mmHg at screening and/or orthostatic hypotension (defined as a difference between sitting and standing systolic blood pressure \>20 mmHg and/or a difference between sitting and standing diastolic blood pressure \>10 mmHg)
- Any clinically important ECG abnormality (including QT interval exceeding 450 ms)
- Recent history (within the last 12 months) of risk factors for development of prolonged QT interval, including cardiac hypertrophy, concomitant diuretic use, hypocalcemia, hypomagnesemia
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01429181
Start Date
January 1 2012
End Date
December 1 2014
Last Update
March 30 2017
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