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Study to Compare Gabapentin to Tramadol in Children

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ClinicalTrials.gov Identifier: NCT02722603
Recruitment Status : Recruiting
First Posted : March 30, 2016
Last Update Posted : September 5, 2017
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Pharmaceutical Research Management srl

Brief Summary:
This study evaluates the efficacy and safety of gabapentin relative to tramadol for the treatment of chronic, neuropathic or mixed pain in the paediatric population. Children from 3 months to less than 18 years of age experiencing moderate to severe chronic pain will receive either gabapentin or tramadol for 15 weeks. The difference in average pain scores between treatment arms at the end of the treatment period will be assessed.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: gabapentin Drug: tramadol Other: placebo tramadol Other: placebo gabapentin Phase 3

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain
U.S. FDA Resources

Arm Intervention/treatment
Experimental: gabapentin / placebo tramadol
gabapentin 75 mg/ml syrup / placebo tramadol, 3 times/day for 15 weeks.
Drug: gabapentin
75 mg/ml gabapentin syrup
Other: 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.
Drug: tramadol
100 mg/ml tramadol oral drops
Other: placebo gabapentin
placebo gabapentin syrup



Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   3 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects with neuropathic or mixed chronic pain
  • subjects with at least moderate pain (pain intensity of ≥4/10 assessed by age-appropriate pain scale)
  • subjects with stable underlying disease condition and treatment.

Exclusion Criteria:

  • pain duration of more than 5 years
  • current use of gabapentin or tramadol
  • history of failure to respond to adequate treatment by gabapentin or tramadol/opioids for neuropathic pain.

Information from the National Library of Medicine

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


Contacts
Contact: Donato Bonifazi 00393287919866 donatobonifazi@pharmsrl.com

Locations
Albania
Qendra Spitalore Universitare Nene Tereza, Tirana Not yet recruiting
Tirana, Albania
Estonia
Sihtasutus Tartu Uelikooli Kliinikum Not yet recruiting
Tartu, Estonia
France
Centre Hospitalier Régional Universitaire de Lille Recruiting
Lille, France
Assistance Publique-Hopitaux de Marseille Not yet recruiting
Marseille, France
Assistance Publique Hôpitaux De Paris - Hôpital Necker de Paris Not yet recruiting
Paris, France
Assistance Publique Hôpitaux De Paris - Hôpital Robert Debré de Paris Recruiting
Paris, France
Germany
Universitaets klinikum Erlangen Not yet recruiting
Erlangen, Germany
Greece
Geniko Nosokomeio Paidon Αthinon I Agia Sophia - Paidon Pentelis Recruiting
Athens, Greece
Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari Not yet recruiting
Bari, Italy
Istituto Giannina Gaslini Genova Not yet recruiting
Genova, Italy
Azienda Ospedaliera Padova Not yet recruiting
Padova, Italy
Netherlands
Erasmus Universitair Medisch Centrum Rotterdam Recruiting
Rotterdam, Netherlands
University Medical Center Utrecht, Wilhelmina Kinderziekenhuis Not yet recruiting
Utrecht, Netherlands
Sponsors and Collaborators
Pharmaceutical Research Management srl
European Commission
Investigators
Principal Investigator: Florentia Kaguelidou Center of Clinical Investigations, INSERM CIC 1426, Hopital Robert Debré, Assistance Publique Hopitaux de Paris

Additional Information:
Publications:
Responsible Party: Pharmaceutical Research Management srl
ClinicalTrials.gov Identifier: NCT02722603     History of Changes
Other Study ID Numbers: GABA-1
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Gabapentin
Tramadol
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents
Analgesics, Opioid
Narcotics