s (p less than 0.0001 for both comparisons),
demonstrating significantly greater reductions in pain compared
with placebo. Pain score averaged over the study periods were
significantly lower than placebo in the DM/Q 45 arm for comparisons
at days 30, 60 and 90 (p less than 0.0001 for each comparison) and
in the DM/Q 30 arm (p less than 0.0001 at days 30 and 60, p=0.0071
at day 90). The consistency in the magnitude of response suggests
that the pain reduction obtained with active treatment relative to
placebo were maintained over the entire study duration.
-- Improvements from baseline with active treatment appeared to
be dose dependent, with the higher dose resulting in improvements
that were almost twice as great as placebo.
-- Both doses demonstrated significantly better improvements in
pain from baseline that were maintained over the duration of the
study.
-- The incidence of AEs was higher in the DM/Q 45 group (91%),
compared with placebo (80%) and DM/Q 30 (79%), with the proportion
of patients discontinuing due to an AE higher in both active
treatments compared with placebo.
-- The most common AEs were dizziness, nausea, diarrhea, fatigue
and somnolence and were generally mild to moderate in severity.
-- There were no statistically significant differences in
serious adverse event rates reported in the DM/Q 45, DM/Q 30 and
placebo groups, and no deaths occurred during the study.
Poster: "IMPROVED PATIENT-CENTERED OUTCOMES WITH
DEXTROMETHORPHAN/ QUINIDINE VS PLACEBO IN A PHASE III,
DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL INVESTIGATING
PAINFUL DIABETIC PERIPHERAL NEUROPATHY," reports on the secondary
efficacy endpoints in the Phase III study on outcomes of importance
to patients, including pain relief, sleep and quality-of-life.
Highlights include:
-- Both Zenvia doses were significantly superior to placebo in
relieving pain. The pattern reported in the Pain Relief Scale
complemented that shown by the Pai
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Page: 1 2 3 4 5 6 7 Related medicine technology :1.
AVANIR Pharmaceuticals to Present Zenvia Phase III Data in Diabetic
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International Society on Thrombosis and Haemostasis4.
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Emerging Growth Opportunities Conference8.
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Data with Rifamycin MMX in Infectious Diarrhea10.
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and Additional Oral and Poster Presentations at the XXI Congress of
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Cyclacel Pharmaceuticals Announces Results of Phase II Seliciclib
Combination Studies