The primary purpose is to investigate the safety and efficacy of SPM927 in patients with Painful Diabetic Neuropathy
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
119
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage 400mg/day, intake in the morning and in the evening, intake for 10 weeks
Placebo tablets two times a day for 10 weeks
The primary objective of this trial is to evaluate the efficacy of SPM 927 in reducing pain in subjects with diabetic distal sensory polyneuropathy
Time frame: Assessments throughout the trial, either daily and/or at clinic visits
Different qualities of neuropathic pain, sleep and activity (daily assessment during entire trial participation)
Time frame: Daily assessment during entire trial participation including visits at the site
Quality of Life and the Profile of Mood States (assessment at site visits during entire trial participation)
Time frame: Daily assessment during entire trial participation including visits at the site
Investigate the tolerability and safety of SPM927 (assessment during entire trial participation)
Time frame: Daily assessment during entire trial participation including visits at the site
Examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)
Time frame: Daily assessment during entire trial participation including visits at the site
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