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Table 4 Exclusion criteria at study periods

From: IMI2-PainCare-BioPain-RCT1: study protocol for a randomized, double-blind, placebo-controlled, crossover, multi-center trial in healthy subjects to investigate the effects of lacosamide, pregabalin, and tapentadol on biomarkers of pain processing observed by peripheral nerve excitability testing (NET)

  Exclusion criteria at study periods: Justification / rationale
33 For female subjects of child bearing potential: positive or missing pregnancy test To protect a fetus
34 Positive or missing urine test for drugs of abuse (opioids, amphetamines, benzodiazepines, cannabinoids). Subject safety and to avoid interactions with, e.g., tapentadol (PD interactions, safety interactions)
35 Blood loss of 500 mL or more (e.g., owing to blood donation) since screening. To ascertain the subject’s suitability for the study
36 Any other reason to exclude the subject according to judgment by the investigator To avoid interference with the purpose of the study.
Temporary exclusion criteria at study periods. The subject is not excluded if some of these temporary exclusion criteria are met at screening of the study period. Instead, the study period may be postponed. If this is the case, all temporary exclusion criteria will be checked again.
37 Alcohol consumption in the last 48 hours prior to the study period. Subject safety and to avoid interactions with, e.g., tapentadol (PD interactions, safety interactions)
38 Intake of any drug including herbal medicines and other remedies except the following: contraceptives; oral paracetamol or ibuprofen up to the maximum recommended dose according SmPC, with last intake for both > 4 days prior to each study period for a self-resolving condition. As described for screening visit
39 Changes in physical exercise activities, e.g., starting workout/training within 1 week prior to the study. To avoid interference with the purpose of the study
40 Current pain within the last 4 days before the study period. To avoid interference with the purpose of the study
41 Any transient, clinically relevant illness within 4 days before the period. To ensure the subject’s good health
42 Incidentally not willing or able to comply with the requirements of the trial protocol or the instructions or to communicate meaningfully with the trial site staff. To ascertain the subject’s suitability for the study
43 Incidentally unable to take oral medication. Requirement for the study
44 Jet lag / irregular working hours / sleep restriction in the last 3 days before the period. To avoid interference with the purpose of the study
  1. Reproduced from [2]