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Study to Compare Gabapentin to Tramadol in Children With Chronic Neuropathic or Mixed Pain

NCT02722603 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2019-10-03

No results posted yet for this study

Summary

This study evaluates the efficacy and safety of gabapentin relative to tramadol for the treatment of chronic, neuropathic or mixed pain in the paediatric population. Children from 3 months to less than 18 years of age experiencing moderate to severe chronic pain will receive either gabapentin or tramadol for 15 weeks. The difference in average pain scores between treatment arms at the end of the treatment period will be assessed.

Conditions

Interventions

DRUG

gabapentin

75 mg/ml gabapentin syrup

DRUG

tramadol

100 mg/ml tramadol oral drops

OTHER

placebo tramadol

placebo tramadol oral drops

OTHER

placebo gabapentin

placebo gabapentin syrup

Sponsors & Collaborators

Principal Investigators

  • Florentia Kaguelidou · Center Clin Investig INSERM CIC 1426 H. R Debré APH de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-12
Primary Completion
2019-05-31
Completion
2019-06-18

Countries

  • Germany
  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02722603 on ClinicalTrials.gov