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Efficacy and safety of the peripheral kappa agonist fedotozine versus placebo in the treatment of functional dyspepsia.

AbstractBACKGROUND:
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.
AuthorsN W Read, J L Abitbol, K D Bardhan, P J Whorwell, B Fraitag
JournalGut (Gut) Vol. 41 Issue 5 Pg. 664-8 (Nov 1997) ISSN: 0017-5749 [Print] England
PMID9414975 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Benzyl Compounds
  • Propylamines
  • Receptors, Opioid, kappa
  • fedotozine
Topics
  • Adolescent
  • Adult
  • Aged
  • Analysis of Variance
  • Benzyl Compounds (therapeutic use)
  • Chi-Square Distribution
  • Double-Blind Method
  • Dyspepsia (drug therapy)
  • Female
  • Humans
  • Male
  • Middle Aged
  • Propylamines (therapeutic use)
  • Receptors, Opioid, kappa (agonists)

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