A multi-center, randomized, double blind, placebo-controlled, phase 2 pilot efficacy study to investigate the efficacy of oral lidocaine (ORE-001) in preventing gastrointestinal disturbance/intolerance in patients after longitudinal laparotomy

Conditions

longitudinal laparotomy

Brief summary

I-FEED score at POD3

Detailed description

I-FEED score at POD1, POD2 and from POD4 at each scheduled time point up to POD8 (with possible extension to POD12), Mean duration patients reach an I-FEED score of 0-2 (in days), Mean duration patients reach increased I-FEED score > 2 (in days), Change of I-FEED scores at each scheduled timepoint, Treatment Emergent Adverse Events (TEAEs) up to EOS (continuous), Treatment Emergent Serious Adverse Events (TESAEs) up to EOS (continuous), Change from Baseline to each scheduled time point up to EOS for Vital signs, Change from Baseline to each scheduled time point up to Day after last study drug administration for ECG, Change from Baseline to each scheduled time point up to Day of last study drug administration for routine laboratory tests and urine analysis, Change from Baseline to Day after last study drug administration for Physical examination, Treatment-emergent AEs leading to premature discontinuation of study drug.

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 (4’s).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
I-FEED score at POD3	—

Secondary

Measure	Time frame
I-FEED score at POD1, POD2 and from POD4 at each scheduled time point up to POD8 (with possible extension to POD12), Mean duration patients reach an I-FEED score of 0-2 (in days), Mean duration patients reach increased I-FEED score > 2 (in days), Change of I-FEED scores at each scheduled timepoint, Treatment Emergent Adverse Events (TEAEs) up to EOS (continuous), Treatment Emergent Serious Adverse Events (TESAEs) up to EOS (continuous), Change from Baseline to each scheduled time point up to EOS for Vital signs, Change from Baseline to each scheduled time point up to Day after last study drug administration for ECG, Change from Baseline to each scheduled time point up to Day of last study drug administration for routine laboratory tests and urine analysis, Change from Baseline to Day after last study drug administration for Physical examination, Treatment-emergent AEs leading to premature discontinuation of study drug.	—

Measure

Time frame

I-FEED score at POD1, POD2 and from POD4 at each scheduled time point up to POD8 (with possible extension to POD12), Mean duration patients reach an I-FEED score of 0-2 (in days), Mean duration patients reach increased I-FEED score > 2 (in days), Change of I-FEED scores at each scheduled timepoint, Treatment Emergent Adverse Events (TEAEs) up to EOS (continuous), Treatment Emergent Serious Adverse Events (TESAEs) up to EOS (continuous), Change from Baseline to each scheduled time point up to EOS for Vital signs, Change from Baseline to each scheduled time point up to Day after last study drug administration for ECG, Change from Baseline to each scheduled time point up to Day of last study drug administration for routine laboratory tests and urine analysis, Change from Baseline to Day after last study drug administration for Physical examination, Treatment-emergent AEs leading to premature discontinuation of study drug.

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Countries

Germany

Outcome results

None listed