Abstract | BACKGROUND: Peripheral kappa receptor agonists may provide a new therapeutic approach for the treatment of functional dyspepsia. AIMS: 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.
|
Authors | N W Read, J L Abitbol, K D Bardhan, P J Whorwell, B Fraitag |
Journal | Gut
(Gut)
Vol. 41
Issue 5
Pg. 664-8
(Nov 1997)
ISSN: 0017-5749 [Print] England |
PMID | 9414975
(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)
|