Efficacy and Safety Study of Gabapentin as add-on to Morphine in Paediatric Patients Affected by Chronic Pain

PHASE2WithdrawnINTERVENTIONAL
0
Timeline

Start Date

April 4, 2017

Primary Completion Date

October 21, 2019

Study Completion Date

October 21, 2019

Conditions
Chronic Pain
Interventions
DRUG

Gabapentin + Morphine

"Gabapentin: liquid oral formulation (syrup) - 75 mg/ml-three times daily. The starting dose during the optimization period will be defined according to 2 weight groups (5-15kg and \>15kg). Dose will be scaled at Day 1,3,5,14,and 21 according to a specific schedule. Maintenance dosing will be scheduled in accordance to the body weight.~Morphine: background therapy as oral, liquid and solid formulations. Patients with BW≤30kg :liquid oral formulation four times daily throughout the whole treatment period. Patients with BM\>30kg : immediate release solid and/or liquid oral formulation four times daily during titration phase and an extended release solid oral formulation twice daily during the maintenance period."

DRUG

Placebo + Morphine

Placebo liquid oral formulation. Morphine: background therapy as oral, liquid and solid formulations. Patients with BW≤30kg :liquid oral formulation four times daily throughout the whole treatment period. Patients with BM\>30kg : immediate release solid and/or liquid oral formulation four times daily during titration phase and an extended release solid oral formulation twice daily during the maintenance period.

All Listed Sponsors
collaborator

European Commission

OTHER

lead

Pharmaceutical Research Management srl

INDUSTRY