Efficacy and safety study to compare gabapentin versus tramadol in paediatric patients affected by chronic moderate to severe pai

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 94

Inclusion Criteria

1. Male or female, aged 3 months to less than 18 years at screening (V1).
Recruitment will start with patients = years until results from the ongoing non-clinical toxicological study will confirm the safety of gapapentin in the age subset 3 months-3 years.
2. Informed consent by parent(s)/legal guardian.
3. Assent by the patient, where applicable.
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.
6. Subjects that present with at least moderate pain as defined by average pain intensity of = 4/10.
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.
Are the trial subjects under 18? yes
Number of subjects for this age range: 94
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 impain pain diagnosis and assessment.
9. Subjects with history of suicidal ideation or behaviour.
10. Subjects with hustory of substance abuse in particular opioids
11. Subjects under prohibited concomitant medication.
12. Subjects in need for corticosteroid oral treatment or corticosteroid infiltration to treat pain caused by infiltration or compression of neural structure.
13. Subjects born prematurely, before the 36th week of 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.
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, hypersensitivity or clinically significant intolerance to gabapentin or tramadol or any component found in the study drugs.
18. Subjects with fructose intolerance, diabetes, glucose-galactose malabsorption pr lactase-isomaltase deficiency.
19. Subjects with clinically relevant abnormal ECG.
20. Subjects participating in another clinical interventional trial.
21. Subjects scheduled for surgery or in recovery from surgery occurring within 3 months of baseline assessment.
22. Female subjects who are pregnant or currently lactating.
23. Subjects that failed screening or were previously enrolled in this study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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