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.
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.
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 (P = .881).
However, post-hoc analyses of the 105 subjects (53 placebo, 52 MSN) with moderate to severe symptoms at baseline (GSA > 2.7) showed a significant MNS treatment effect from week 1 to 3 (P P
Treatment-emergent adverse events were primarily mild to moderate with headache and abdominal pain reported most often, with no tardive dyskinesia reported.
“This study, although the primary endpoint was not met using all enrolled patients, demonstrated that MNS is well-tolerated and effective in reducing symptoms of gastroparesis, particularly nausea and abdominal pain, in women with moderate to severe baseline symptoms. The findings from this study and others support the use of MNS in treating diabetic gastroparesis,” the authors conclude.
The study, with first author Richard McCallum, MD, Texas Tech University Health Sciences Center in El Paso, was published online in Clinical Gastroenterology and Hepatology.
The study enrolled only women, based on earlier data showing significant symptomatic improvement with MNS in women but not men. The 4-week treatment period may be too short to identify tardive dyskinesia as a side effect. The sample size of 205 patients was powered for the primary endpoint involving all patients enrolled, but not for the post-hoc moderate to severe subgroup analysis.
The study was funded by Evoke Pharma Inc., which makes metoclopramide nasal spray. McCallum and four co-authors have disclosed financial relationships with the company.
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Publish date : 2023-11-27 13:29:00
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