Erythromycin and related macrolides for gastroparesis

To assess the effects of erythromycin (including derivatives) for symptomatic control and gastric emptying in adults with gastroparesis.

Primary objective

To compare erythromycin or other macrolides (e.g. clarithromycin, roxithromycin) or derivatives (e.g. mitemcinal) versus control (no treatment; placebo; other prokinetics such as metoclopramide, domperidone or tegaserod; antiemetics including phenothiazines, antihistamines or serotonin 5-HT receptor antagonists; or low-dose tricyclic antidepressants for symptomatic control of gastroparesis (nausea, vomiting, early satiety and abdominal pain as a composite outcome) in adults with gastroparesis.

Secondary objectives

To compare the safety (i.e. the occurrence of any grade 3 or 4 adverse event as defined by the National Institute of Allergy and Infectious Diseases (NIAID) program of the National Institute of Health (NIH), USA; NIAID 2003) of erythromycin (or other macrolide or its derivative) versus control (no treatment, placebo, prokinetic, antiemetic or low-dose tricyclic antidepressant) in adults with gastroparesis.

To compare erythromycin (or other macrolide or its derivatives) versus control (no treatment, placebo, prokinetic, antiemetic or low-dose tricyclic antidepressant) for gastric emptying in adults with gastroparesis.

To conduct a subgroup analysis within each comparison according to:

  • type of control intervention (no treatment, placebo, prokinetic, antiemetic or low-dose tricyclic antidepressant);
  • type of etiology of gastroparesis (DM, connective tissue diseases, neurologic diseases, autoimmune diseases, iatrogenic (drug-related, e.g. calcium channel blockers, opiates, lithium) diseases or idiopathic diseases.

This is a protocol.

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