Cross-over Multiple Dose Study Assessing the Analgesic Efficacy and Safety of Oral GRT9906 Compared to Placebo in Subjects With Primary Fibromyalgia Syndrome

The study was performed in participants suffering from fibromyalgia and investigated efficacy after treatment with several doses of GRT9906 versus placebo. Furthermore, it was to be found out if treatment with GRT9906 was safe and well-tolerated.

开始日期2005-09-19

申办/合作机构

Grünenthal GmbH

EUCTR2005-001404-40-DK / Not yet recruiting临床2期

Cross-over multiple dose study assessing the analgesic efficacy and safety of oral GRT9906 PR compared to active comparator and placebo in subjects with painful polyneuropathy of mixed origin

开始日期2005-09-02

申办/合作机构

Grünenthal GmbH

NCT03776110 / Completed临床1期

Phase I, Single-center, Multiple Dose, Dose Escalation Study (Within Dose-group Randomised, Double-blind, Placebo-controlled, 2-way Cross-over) to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT9906 Prolonged Release Tablets in Healthy Male and Female Subjects

The safety and tolerability of multiple oral administrations of GRT9906 at different doses was investigated in this clinical study. The prolonged-release tablets slowly release the active compound in the intestine. In addition, absorption into the body, distribution, metabolization and excretion of GRT9906 was characterized. Pharmacological effects of GRT9906 in healthy participants was assessed using pupillometry (diameter and reactions of the pupil) and a Cold Pressor Test where pain is measured while hands are placed in icy water for two minutes.

开始日期2004-09-15

申办/合作机构

Grünenthal GmbH

100 项与法塞拉多相关的临床结果

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100 项与法塞拉多相关的转化医学

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100 项与法塞拉多相关的专利（医药）

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项与法塞拉多相关的文献（医药）

2012-07-01·European Journal of Pain2区 · 医学

Randomized controlled trial of the combined monoaminergic and opioid investigational compound GRT9906 in painful polyneuropathy

2区 · 医学

Article

作者: Meier, T. ; Ashworth, J. ; Lehmann, R. ; Sindrup, S.H. ; Jensen, T.S. ; Winkel, M. ; Konder, R. ; Baron, R.

AbstractGRT9906 is an investigational novel compound with μ‐opioid receptor agonism and inhibition of noradrenalin/serotonin re‐uptake. In this randomized, double‐blind, placebo‐controlled, three‐way cross‐over trial in painful polyneuropathy, the efficacy and safety of GRT9906 was assessed and compared with tramadol. During 4‐week treatment periods, daily oral doses of either GRT9906 120–240 mg, or placebo, or tramadol 200–400 mg were given. These were separated by 1‐week washout periods. The primary endpoint was the average pain intensity (average of daily current pain intensity over the last 3 days of each treatment period rated on a 0 to 10‐point numeric rating scale). One hundred seventeen patients were enrolled and 64 were randomized to one of six treatment sequences. Forty‐seven patients qualified for the per protocol analysis. GRT9906 reduced average pain intensity by 2.1 points compared with a reduction of 0.6 points on placebo (p < 0.0001) and 2.4 points on tramadol. GRT9906 also improved scores on the sleep problem scale and the neuropathic pain symptom inventory and scored better than placebo on the patient global impression of change. Numbers needed to treat to obtain one patient with more than 50% pain relief was 3.9 (95% CI 2.4–11.5) for both GRT9906 and tramadol. The most frequently reported adverse events were nausea, fatigue, constipation and sleep disorder for GRT9906 and tramadol. Four patients dropped out due to adverse events during both GRT9906 and tramadol treatment and two dropped out during placebo treatment. In conclusion, in painful polyneuropathy, GRT9906 demonstrated analgesic efficacy with a magnitude of effect comparable with tramadol and was well tolerated.

100 项与法塞拉多相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10007	法塞拉多	-	-

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
纤维肌痛	临床2期	美国	Grünenthal GmbH	2005-09-19
慢性疼痛	临床2期	德国	Grünenthal GmbH	2003-10-22
慢性疼痛	临床2期	德国	Grunenthal SA	2003-10-22
内脏疼痛	临床2期	德国	Grünenthal GmbH	2003-10-22
内脏疼痛	临床2期	德国	Grunenthal SA	2003-10-22
神经痛	临床2期	德国	Grünenthal GmbH	-
神经痛	临床2期	丹麦	Grünenthal GmbH	-
神经痛	临床2期	英国	Grünenthal GmbH	-