Efficacy and Safety Study of Gabapentin as add-on to Morphine in Paediatric Patients Affected by Chronic Pain (GABA-2)
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|ClinicalTrials.gov Identifier: NCT03275012|
Recruitment Status : Not yet recruiting
First Posted : September 7, 2017
Last Update Posted : September 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Gabapentin + Morphine Drug: Placebo + Morphine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized, Double-blind, Placebo Controlled, Superiority Phase II Study to Evaluate the Safety, Pharmacokinetic, Efficacy of Gabapentin as add-on to Morphine in Children From 3 Months to Less Than 18 Years|
|Estimated Study Start Date :||October 1, 2017|
|Estimated Primary Completion Date :||March 3, 2018|
|Estimated Study Completion Date :||March 3, 2019|
Experimental: Group 1
Gabapentin + Morphine
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.
Placebo Comparator: Group 2
Placebo + Morphine
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.
- Average pain scores [ Time Frame: through study completion- 1 year and 8 months ]The primary endpoint of this study is the average pain scores in the two treatment groups assessed by age-appropriate pain scales
- Percentage of responders [ Time Frame: though study completion-1 year and 8 months ]Percentage of responders to treatments, defined as subjects with a 30% reduction from baseline in assessment scale
- Participant dropouts [ Time Frame: through study completion-1 year and 8 months ]Participant dropouts due to lack of adequate pain response.
- Total dose of rescue drug [ Time Frame: through study completion-1 year and 8 months ]The total cumulative weight normalized dose of each rescue drug.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275012
|Contact: Donato Bonifazi, Dremail@example.com|
|Qendra Spitalore Universitare Nene Tereza||Not yet recruiting|
|Centre Hospitalier Regional Universitaire de Lille|
|Assistance Publique-Hopitaux de Marseille|
|Assistance Publique Hopitaux De Paris - Hopital Necker de Paris|
|Hopital Robert Debré Assistance Publique-Hopitaux de Paris||Not yet recruiting|
|Universitaetsklinikum Erlangen Department of Paediatrics and Adolescent Medicine||Not yet recruiting|
|Geniko Nosokomeio Paidon I Agia Sofia||Not yet recruiting|
|Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari|
|Istituto Giannina Gaslini||Not yet recruiting|
|Azienda Ospedaliera di Padova|
|Erasmus Unversitair Medisch Centrum Rotterdam||Not yet recruiting|
|University Medical Center Utrecht, Wilhelmina Kinderziekenhuis|
|Principal Investigator:||Saskia De Wildt, MD-PhD||Erasmus Medical Center|