A Study to Assess the Safety and Efficacy of 7 Days Treatment With a Novel Analgesic in Subjects With Peripheral Neuropathic Pain
Condition: Neuralgia
MeSH terms: Neuralgia
Intervention: GRT6010; Pregabalin; Matching Placebo
Intervention description: Oral solution given once daily.; Over-encapsulated pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7.; Matching Placebo capsules to the over-encapsulated Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.
Capsules twice daily on Days 1 to 7. Solution once daily.
Intervention MeSH terms: Pregabalin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 114.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: neuralgia; postherpetic

Summary:

      The purpose of this trial is to determine whether a novel analgesic is effective in treating
      of neuropathic pain caused by herpetic infection, surgery, or trauma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years to 75 years

          -  Presence of persistent neuropathic pain for at least 6 months at the time of the
             Enrollment Visit. Allowed reasons for neuropathic pain are: modified radical
             mastectomy, breast conserving surgery, or cosmetic breast surgery. [Germany: subjects
             after cosmetic breast surgery may not be enrolled.]

          -  Presence of "probable" or "definite" neuropathic pain.

          -  Presence of dynamic mechanical allodynia on the affected side, or alternatively, the
             mechanical pain sensitivity for any of the pinprick stimuli is higher on the affected
             compared to the contralateral side.

          -  At either Visit 5 or Visit 6: Presence of an average evoked pain intensity score of
             >20 on the 0 100 point numeric rating scale (NRS) for at least 1 of the 3 clinical
             sub-tests for dynamic mechanical allodynia (i.e., standardized brush, cotton wool tip
             or cotton wisp). The average will be calculated as the arithmetic mean of all
             measurements per sub test. Alternatively, the arithmetic mean of the 5 test replicates
             for any of the pinprick stimuli for mechanical pain sensitivity is at least 3 times
             higher for the affected side compared to the contralateral side.

          -  Presence of an average ongoing pain intensity score of >4 to <9 on the 0-10 point
             numerical rating scale (NRS) without the use of rescue medication within the 3 day
             Baseline pain intensity evaluation Period with at least 7 of 9 assessments being
             present.

          -  Dissatisfaction with the current treatment (i.e., lack of efficacy or intolerable side
             effects) if taking an opioid or non opioid analgesic medication for the painful
             neuropathy before enrollment.

        Exclusion Criteria:

          -  Any kind of hepatic impairment at Visit 1 or at Visit 3.

          -  Either active hepatitis within the past 3 months or presence of chronic hepatitis
             irrespective of its activity status.

          -  Estimated creatinine clearance of less than 60 mL/minute x 1.73 m2 at either Visit 1
             or at Visit 3.

          -  Clinically relevant cardiac disease (e.g., unstable angina pectoris, angina pectoris
             Canadian Cardiovascular Society [CCS] Grade III to IV, acute myocardial infarction
             within the last 3 months, cardiac insufficiency New York Heart Association [NYHA]
             Class III to IV).

          -  Electrocardiogram (ECG) with clinically relevant findings at either Visit 1 or at
             Visit 3, including but not limited to repeated prolongation of QTc > 450 ms
             (Fridericia correction), or a history of additional risk factors for torsade de
             pointes (e.g., family history of Long QT Syndrome).

          -  Clinically relevant pulmonary disease (e.g., Medical Research Council breathlessness
             scale of 2 or above).

          -  Specific antitumor therapy within the last 6 months, e.g., adjuvant radiotherapy or
             chemotherapy, biologics, or angiogenesis inhibitors.

          -  CYP2D6 poor metabolizer phenotype as predicted by CYP2D6 genotyping.

          -  Presence of confounding pain conditions (e.g., ulnar nerve entrapment, radial nerve
             injury associated with major soft-tissue or bone damage, cervico-thoracic
             radiculopathy, carpal tunnel syndrome, chemotherapy-induced peripheral neuropathy, or
             complex regional pain syndrome type I or type II).

          -  Phantom breast or phantom limb pain.

          -  Presence of exclusively negative symptoms of neuropathic pain (e.g., hypoesthesia or
             total anesthesia) in the affected area.