Study to Compare Gabapentin to Tramadol in Children
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02722603|
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : September 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: gabapentin Drug: tramadol Other: placebo tramadol Other: placebo gabapentin||Phase 3|
Gabapentin is indicated for the treatment of peripheral neuropathic pain in adults. In the absence of specific paediatric studies, it is not approved for the same condition in children.
The paediatric use of gabapentin is hampered by a) the lack of a suitable paediatric formulation, b) the significant variability of gabapentin pharmacokinetics profile and c) efficacy and safety data in this specific population.
The GABA-1 study is designed to demonstrate the efficacy of gabapentin oral solution relative to tramadol and to document the Pharmacokinetic and safety profile of gabapentin in this indication.
GABA-1 is a non-inferiority trial because gabapentin is expected to be equally effective but better tolerated than tramadol, thus providing a clinical benefit to affected children.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Estimated Study Start Date :||September 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: gabapentin / placebo tramadol
gabapentin 75 mg/ml syrup / placebo tramadol, 3 times/day for 15 weeks.
75 mg/ml gabapentin syrupOther: placebo tramadol
placebo tramadol oral drops
Active Comparator: tramadol / placebo gabapentin
tramadol oral drops 100 mg/ml / placebo gabapentin, 3 times/day for 15 weeks.
100 mg/ml tramadol oral dropsOther: placebo gabapentin
placebo gabapentin syrup
- Average pain score, assessed by age-appropriate pain scales. [ Time Frame: 15 weeks drug treatment ]Pain level will be measured at baseline (before starting drug therapy) and after 15 weeks of drug treatment
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): NCT02722603
|Contact: Donato Bonifazifirstname.lastname@example.org|
|Qendra Spitalore Universitare Nene Tereza, Tirana||Not yet recruiting|
|Sihtasutus Tartu Uelikooli Kliinikum||Not yet recruiting|
|Centre Hospitalier Régional Universitaire de Lille||Recruiting|
|Assistance Publique-Hopitaux de Marseille||Not yet recruiting|
|Assistance Publique Hôpitaux De Paris - Hôpital Necker de Paris||Not yet recruiting|
|Assistance Publique Hôpitaux De Paris - Hôpital Robert Debré de Paris||Recruiting|
|Universitaets klinikum Erlangen||Not yet recruiting|
|Geniko Nosokomeio Paidon Αthinon I Agia Sophia - Paidon Pentelis||Recruiting|
|Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari||Not yet recruiting|
|Istituto Giannina Gaslini Genova||Not yet recruiting|
|Azienda Ospedaliera Padova||Not yet recruiting|
|Erasmus Universitair Medisch Centrum Rotterdam||Recruiting|
|University Medical Center Utrecht, Wilhelmina Kinderziekenhuis||Not yet recruiting|
|Principal Investigator:||Florentia Kaguelidou||Center of Clinical Investigations, INSERM CIC 1426, Hopital Robert Debré, Assistance Publique Hopitaux de Paris|