Skip to content

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

TerminatedPhase 3NCT02722603
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Randomized, Double-blind, Double-dummy, Active Controlled, Multicentre, Non-inferiority Phase-III Study to Compare Gabapentin Liquid Formulation to Tramadol in Children Experiencing Moderate to Severe Chronic Neuropathic or Mixed Pain
Conditions
Interventions
Sponsor
Pharmaceutical Research Management srl
Collaborators
European Commission
Start date
2018-09-12
Primary completion
2019-05-31
Sex
All
Age range
from 3 Months to 17 Years
Results posted
No results posted in this snapshot
Countries
Germany, Netherlands
Total sites listed
2

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Male or female, aged 3 months to less than 18 years at screening. 2. Informed consent by parent(s) and/or legal guardian according to each country legal requirement. 3. Assent by the patient, where applicable, according to each country legal requirement. 4. Subjects that meet the diagnostic criteria for neuropathic or mixed pain. 5. Subjects that present with chronic pain defined as the recurrent or continuous pain persisting more than 3 months. Duration of pain will be determined from the date of the first pain experienced. 6. Subjects that present with at least moderate pain as defined by average pain intensity of ≥4/10 as assessed during a 3-day screening period 7. Stable underlying disease condition and treatment. 8. In presence of malignant diseases, subjects in clinical remission and/or no expected changes in their therapeutic protocol during participation to the present study. Exclusion Criteria: 1. Pain duration of more than 5 years. 2. Current use of gabapentin or tramadol. 3. History of failure to respond to adequate treatment by gabapentin or tramadol/opioids for neuropathic pain. 4. History of epileptic condition except febrile seizure disorder. 5. Subjects with sleeping apnoea syndrome of any origin or subjects with history of severe respiratory impairment. 6. Subjects with diagnosis of sickle cell disease. 7. Subjects that present significant cognitive impairment. 8. Subjects that present current, controlled or uncontrolled, co-morbid psychiatric diagnosis that can impair pain diagnosis and assessment such as severe depressive conditions or psychosis. 9. Subjects with history of suicidal ideation or behaviour. 10. History of substance abuse in particular opioids. 11. Subjects under prohibited concomitant medication 12. Subjects in need for corticosteroid oral treatment or corticosteroid infiltrations to treat pain caused by infiltration or compression of neural structures, e.g. peripheral nerves or spinal cord. 13. Subjects born prematurely at ≤ 36 weeks gestational age, if recruited during the first year of age. 14. Subjects with a body mass index (BMI) for age and gender of \< 5th percentile or \> 95th percentile. 15. Subjects with glomerular filtration rate \< 90 mL/min/1.73 m2 (Schwarz equation). 16. Subjects with significant hepatic impairment or with Aspartate Transaminase (AST) or Alanine Transaminase (ALT) enzymes 3 times the upper limit of the age-specific reference range. 17. Subjects with known allergy, hyper…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02722603