Efficacy and safety of the peripheral kappa agonist fedotozine versus placebo in the treatment of functional dyspepsia.
Gut
; 41(5): 664-8, 1997 Nov.
Article
en En
| MEDLINE
| ID: mdl-9414975
ABSTRACT
BACKGROUND:
Peripheral kappa receptor agonists may provide a new therapeutic approach for the treatment of functional dyspepsia.AIMS:
To evaluate, in a large multicentre trial, the use of the kappa receptor agonist fedotozine to improve symptoms associated with functional dyspepsia.METHODS:
Two or more of the following persistent symptoms were required for inclusion epigastric pain, early satiety, epigastric fullness or distension, nausea, vomiting, and a feeling of slow digestion. On completing a two week placebo washout, 271 patients were randomised into two groups to receive 30 mg fedotozine three times daily or placebo for six weeks under double blind conditions.RESULTS:
The improvement in the overall intensity of dyspeptic symptoms (main efficacy criterion) was significantly more pronounced in the fedotozine group (p = 0.002) compared with placebo, as was epigastric pain (p = 0.004) and nausea (p = 0.01); the improvement in postprandial fullness was nearly significant (p = 0.052). Inability to finish a meal and slow digestion were unaffected. The patient global score, the average of the five individual symptoms, was notably ameliorated with fedotozine (p = 0.021). The safety of fedotozine was excellent.CONCLUSIONS:
Fedotozine at 30 mg three times daily is safe and more effective than placebo for the relief of key symptoms associated with functional dyspepsia.
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Propilaminas
/
Compuestos de Bencilo
/
Receptores Opioides kappa
/
Dispepsia
Tipo de estudio:
Clinical_trials
Límite:
Adolescent
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Adult
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Aged
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Female
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Humans
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Male
/
Middle aged
Idioma:
En
Revista:
Gut
Año:
1997
Tipo del documento:
Article
País de afiliación:
Reino Unido