TOPLINE:
Metoclopramide nasal spray (MNS) reduces symptoms of diabetic gastroparesis, especially the two cardinal symptoms of nausea and abdominal pain, in women with moderate to severe baseline symptoms, results of a phase 3 study indicate.
METHODOLOGY:
A total of 205 adult women (mean age, 52.7 years) with diabetic gastroparesis and delayed gastric emptying were randomly allocated (1:1) to placebo or MNS administered in either nostril, four times daily, 30 minutes before meals and at bedtime, for 28 days.
Subjects were required to complete a daily symptom diary and to have a mean daily Gastroparesis Symptom Assessment (GSA) total score between ≥ 1.4 and ≤ 3.5 during the qualification period and the baseline. The GSA daily diary is a validated patient-reported outcome tool that averages scores of nausea, early satiety, prolonged fullness, bloating, and upper abdominal pain on a 5-point ordinal scale.
The primary efficacy endpoint was a change in mean daily GSA total score from baseline to week 4.
Due to US Food and Drug Administration guidance regarding gastroparesis medications that was issued after the study began, researchers conducted post-hoc analyses on subjects with moderate to severe gastroparesis at baseline.
TAKEAWAY:
In the overall study population (mean GSA, 2.29), the MNS group did not experience a significant reduction in symptoms compared with the placebo group from baseline to week 4 (
