Randomized, double-blind, placebo controlled, multi-centre superiority phase II study to evaluate the safety, pharmacokinetic, efficacy of gabapentin liquid formulation as add-on to morphine in children from 3 months to less than 18 years of age experiencing severe chronic neuropathic or mixed pain.
- Conditions
- Neuropathic pain10029305
- Registration Number
- NL-OMON45684
- Lead Sponsor
- Pharm SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 6
1. 3 months-< 18 years
2. Informed consent
3. Meet diagnostic criteria for chronic neuropathic or mixed pain
4. Severe pain as defined as an average pain score of >= 7/10
5. Stabel underlying disease condition and treatment
6. Patients with chemotherapy induced neuropathic pain: clinical remission or maintenance phase of treatment protocol
1. Pain duration of more than 5 years
2. Current use of gabapentin or strong opoids
3. History of failure to respond to adequate treatment by gabapentin or opioids for neuropathic pain. 4. History of epileptic condition except febrile seizure disorder.
5. Subjects with diagnosis of sickle cell disease.
6. Subjects that present significant cognitive impairment.
7. 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.
8. Subjects with history of or current suicidal ideation or behaviour.
9. Subjects with a history of substance abuse in particular opoids
10. Subjects under prohibited concomitant medication (refer to specific protocol section 5.6.3.1 *Prohibited medications*).
11. 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.
12. Subjects old with a body mass index (BMI) for age and gender of < 5th percentile or > 95th percentile (charts provided as Appendix 5).
13. Subjects with glomerular filtration rate < 90 mL/min/1.73 m2 (Schwarz equation).
14. Subjects with significant hepatic impairment with Aspartate Transaminase (AST) and Alanine Transaminase (ALT) enzymes 3 times the upper limit of the age-specific reference range.
15. Subjects with known allergy, hypersensitivity or clinically significant intolerance to gabapentin or any component found in the study drugs.
16. Subjects with clinically relevant abnormal ECG at the screening visit in the discretion of the investigator/cardiologist.
17. Subjects participating in another clinical interventional trial.
18. Subjects scheduled for surgery or in recovery from surgery occurring within 3 months of baseline assessment.
19. Female subjects who are pregnant or currently lactating.
20. Subjects that failed screening or was previously enrolled in this study.
21. Subjects with fructose intolerance, diabetes, glucose-galactose malabsorption or lactase-isomaltase deficiency.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Average pain score at the end of the treatment period (average of 2 measures<br /><br>each day for 3 days before end of study visit, V10) as assessed by<br /><br>age-appropriate pain scales (FLACC, FPS-R, NRS-11). </p><br>
- Secondary Outcome Measures
Name Time Method