A Double-Blinded, Placebo-Controlled Exploratory Study to Investigate the Efficacy and Safety of Flexible dosing of Oral Lidocaine (ORE-001) to Reduce Abdominal Discomfort and Prevent Early Satiety in Anorexia Nervosa Patients

Conditions

Anorexia nervosa

Brief summary

Difference between ORE-001 and placebo in change from baseline in VAS scores for satiety sensations on Day 28

Detailed description

Difference between ORE-001 and placebo in change from baseline in late fullness (prior to lunch) in VAS scores for satiety sensations on Day 28, Difference between ORE-001 and placebo in change from baseline in VAS score for GI symptoms on Day 28, Difference between ORE-001 and placebo in change from baseline in body weight at Day 28., Daily change from baseline in the weight of food and calorie intake per meal., Difference between ORE-001 and placebo in change from baseline in total IEDOQL score on Day 28., Difference between ORE-001 and placebo in change from baseline in MOS sleep scale on Day 28., Treatment-Emergent Adverse Events (AE) and serious adverse events (SAE) up to end of study, Change from Baseline in the levels of biomarkers (Leptin, ghrelin, oxytocin, peptide Y (PYY), and brain-derived neurotropic factor (BDNF)) associated with satiety at End of Treatment

Related papers

No related papers found yet.

Interventions

DRUGComposition [mg/tablet]: Microcrystalline cellulose 243.9

DRUGSodium bicarbonate 15.9

DRUGHydroxypropyl methylcellulose 47.7

DRUGSodium croscarmellose 4.5

DRUGSilicon dioxide 3.2

DRUGMagnesium stearate plant 3.2

DRUGEudragit E PO Ready Mix 12.7

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Difference between ORE-001 and placebo in change from baseline in VAS scores for satiety sensations on Day 28	—

Secondary

Measure	Time frame
Difference between ORE-001 and placebo in change from baseline in late fullness (prior to lunch) in VAS scores for satiety sensations on Day 28, Difference between ORE-001 and placebo in change from baseline in VAS score for GI symptoms on Day 28, Difference between ORE-001 and placebo in change from baseline in body weight at Day 28., Daily change from baseline in the weight of food and calorie intake per meal., Difference between ORE-001 and placebo in change from baseline in total IEDOQL score on Day 28., Difference between ORE-001 and placebo in change from baseline in MOS sleep scale on Day 28., Treatment-Emergent Adverse Events (AE) and serious adverse events (SAE) up to end of study, Change from Baseline in the levels of biomarkers (Leptin, ghrelin, oxytocin, peptide Y (PYY), and brain-derived neurotropic factor (BDNF)) associated with satiety at End of Treatment	—

Measure

Time frame

Difference between ORE-001 and placebo in change from baseline in late fullness (prior to lunch) in VAS scores for satiety sensations on Day 28, Difference between ORE-001 and placebo in change from baseline in VAS score for GI symptoms on Day 28, Difference between ORE-001 and placebo in change from baseline in body weight at Day 28., Daily change from baseline in the weight of food and calorie intake per meal., Difference between ORE-001 and placebo in change from baseline in total IEDOQL score on Day 28., Difference between ORE-001 and placebo in change from baseline in MOS sleep scale on Day 28., Treatment-Emergent Adverse Events (AE) and serious adverse events (SAE) up to end of study, Change from Baseline in the levels of biomarkers (Leptin, ghrelin, oxytocin, peptide Y (PYY), and brain-derived neurotropic factor (BDNF)) associated with satiety at End of Treatment

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Countries

Italy

Outcome results

None listed