A placebo controlled, randomized, double-blind, dose titration phase 2, safety and efficacy study of ORE-001 (oral lidocaine) in underweight elderly participants

Conditions

Underweight

Brief summary

Change from baseline in the weight of food intake of a standardized lunch on treatment day 1., Change from baseline in the weight of food intake of a standardized lunch on treatment day 42.

Detailed description

Change from baseline in the weight of food intake of a standardized lunch over time (i.e., on treatment days 7 and 14)., Change from baseline in VAS scores for appetite sensations in the difference before and after consumption of a standardized lunch over time (i.e., on treatment days 1, 7, 14, and 42), Change from baseline in VAS scores for GI symptoms in the difference before and after consumption of a standardized lunch over time (i.e., on treatment days 1, 7, 14 and 42)., Change from baseline in body weight over time (i.e., on treatment days 1, 7, 14, and 42), SF-6D score over time (at baseline and on treatment day 42)., PGI-S score over time (at baseline and on treatment day 42)., PGI-I score on treatment day 42., Occurrence of Treatment-Emergent AEs up to end of study., Occurrence of Treatment-Emergent SAEs up to end of study.

Related papers

No related papers found yet.

Interventions

DRUGThe placebo tablets are white to off-white

DRUGround

DRUGfilm-coated tablets with a diameter of approximately 10 mm. The placebo tablets are packaged in pvc/alu blisters.

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from baseline in the weight of food intake of a standardized lunch on treatment day 1., Change from baseline in the weight of food intake of a standardized lunch on treatment day 42.	—

Secondary

Measure	Time frame
Change from baseline in the weight of food intake of a standardized lunch over time (i.e., on treatment days 7 and 14)., Change from baseline in VAS scores for appetite sensations in the difference before and after consumption of a standardized lunch over time (i.e., on treatment days 1, 7, 14, and 42), Change from baseline in VAS scores for GI symptoms in the difference before and after consumption of a standardized lunch over time (i.e., on treatment days 1, 7, 14 and 42)., Change from baseline in body weight over time (i.e., on treatment days 1, 7, 14, and 42), SF-6D score over time (at baseline and on treatment day 42)., PGI-S score over time (at baseline and on treatment day 42)., PGI-I score on treatment day 42., Occurrence of Treatment-Emergent AEs up to end of study., Occurrence of Treatment-Emergent SAEs up to end of study.	—

Measure

Time frame

Change from baseline in the weight of food intake of a standardized lunch over time (i.e., on treatment days 7 and 14)., Change from baseline in VAS scores for appetite sensations in the difference before and after consumption of a standardized lunch over time (i.e., on treatment days 1, 7, 14, and 42), Change from baseline in VAS scores for GI symptoms in the difference before and after consumption of a standardized lunch over time (i.e., on treatment days 1, 7, 14 and 42)., Change from baseline in body weight over time (i.e., on treatment days 1, 7, 14, and 42), SF-6D score over time (at baseline and on treatment day 42)., PGI-S score over time (at baseline and on treatment day 42)., PGI-I score on treatment day 42., Occurrence of Treatment-Emergent AEs up to end of study., Occurrence of Treatment-Emergent SAEs up to end of study.

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Countries

Netherlands

Outcome results

None listed