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Clinical Trials/EUCTR2019-001885-14-HU
EUCTR2019-001885-14-HU
Active, not recruiting
Phase 1

The prognostic value of Biomarkers and the Effect of Tolperisone in Acute low back pain and sciatic pain – BETA A Phase 3 investigator initiated study - BETA

ational Research, Development and Innovation Office0 sites150 target enrollmentMay 29, 2019
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DrugsMiderizone 150 mg tablet

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
ational Research, Development and Innovation Office
Enrollment
150
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 29, 2019
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
ational Research, Development and Innovation Office

Eligibility Criteria

Inclusion Criteria

  • •Patients aged 18\-80 years with acute (less than 1\-month) low back pain with or without radicular signs, who do not have severe diseases (abscess, tumor etc) in the background, had CT or MRI scan, and who has given written consent to participte in the study.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 100
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 50

Exclusion Criteria

  • •Pregnancy, hypesensitivity to tolperisone in the history, severe liver or kidney disease, other severe diseases (abscess, tumor etc) in the background of pain.

Outcomes

Primary Outcomes

Not specified

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