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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of the study is to evaluate the efficacy of gabapentin as adjunctive therapy to morphine in the treatment of severe chronic neuropathic or mixed pain in children from 3 months to less than 18 years of age assessed by the difference in average pain scores between treatment arms at the end of the treatment period.

Condition or disease Intervention/treatment Phase
Chronic Pain Drug: Gabapentin + Morphine Drug: Placebo + Morphine Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Anticipated Study Start Date : October 1, 2017
Estimated Primary Completion Date : March 3, 2018
Estimated Study Completion Date : March 3, 2019

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Participant dropouts [ Time Frame: through study completion-1 year and 8 months ]
    Participant dropouts due to lack of adequate pain response.

  3. 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.


Eligibility Criteria

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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:

  1. Male or female, aged 3 months to less than 18 years at screening (V1)
  2. Informed consent by parent(s) and/or legal guardian according to each country legal requirement.
  3. Assent, where applicable, according to each country legal requirement.Informed (co-) consent of child, where applicable, according to each country legal requirement.
  4. Subjects that meet the diagnostic criteria for neuropathic or mixed pain.
  5. Subjects that present with chronic pain defined as the recurrent or continuous pain persisting more than 3 months.
  6. Subject that present with severe pain as defined by average pain intensity of ≥7 /10 as assessed during a 3-day screening period
  7. Stable underlying disease condition and treatment.
  8. Patients with Chemotherapy Induced Peripheral Neuropathy, when in clinical remission or maintenance phase of their therapeutic protocol.

Exclusion Criteria:

  1. Pain duration of more than 5 years.
  2. Current use of gabapentin.
  3. Current use of strong opioids (morphine, methadone, fentanyl, ketamine, oxycodone).
  4. History of failure to respond to adequate treatment by gabapentin or opioids for neuropathic pain.
  5. History of epileptic condition (except febrile seizure disorder).
  6. Subjects with diagnosis of sickle cell disease.
  7. Subjects that present significant cognitive impairment.
  8. 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.
  9. Subjects with history of or current suicidal ideation or behaviour.
  10. Subjects with history of substance abuse in particular opioids.
  11. Subjects under prohibited concomitant medication .
  12. Subjects with a body mass index (BMI) for age and gender of < 5th percentile or > 95th percentile (charts provided as Appendix 3).
  13. Subjects with significant renal impairment, i.e., glomerular filtration rate < 90 mL/min/1.73 m2 (Revised Schwarz equation).
  14. Subjects with significant hepatic impairment or with Aspartate Transaminase (AST) or Alanine Transaminase (ALT) enzymes 3 times the upper limit of the age-specific reference range.
  15. 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.
  16. Subjects with clinically relevant abnormal ECG at the screening visit in the discretion of the Investigator/cardiologist.
  17. Subjects with known allergy, hypersensibility or clinically significant intolerance to gabapentin or any component found in the study drugs.
  18. Subjects with fructose intolerance, diabetes, glucose-galactose malabsorption or lactase-isomaltase deficiency.
  19. Subjects participating in another clinical interventional trial.
  20. Subjects scheduled for surgery or in recovery from surgery occurring within 3 months of baseline assessment.
  21. Female subjects who are pregnant or currently lactating.
  22. Subjects that failed screening or were previously enrolled in this study
  23. Patients with Chemotherapy Induced Peripheral Neuropathy, when in induction phase of their therapeutic protocol
Contacts and Locations

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): NCT03275012


Contacts
Contact: Donato Bonifazi, Dr +393287919866 donatobonifazi@pharmsrl.com

Locations
Albania
Qendra Spitalore Universitare Nene Tereza Not yet recruiting
Tirana, Albania
France
Centre Hospitalier Regional Universitaire de Lille
Lille, France
Assistance Publique-Hopitaux de Marseille
Marseille, France
Assistance Publique Hopitaux De Paris - Hopital Necker de Paris
Paris, France
Hopital Robert Debré Assistance Publique-Hopitaux de Paris Not yet recruiting
Paris, France
Germany
Universitaetsklinikum Erlangen Department of Paediatrics and Adolescent Medicine Not yet recruiting
Erlangen, Germany
Greece
Geniko Nosokomeio Paidon I Agia Sofia Not yet recruiting
Athens, Greece
Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
Bari, Italy
Istituto Giannina Gaslini Not yet recruiting
Genova, Italy
Azienda Ospedaliera di Padova
Padova, Italy
Netherlands
Erasmus Unversitair Medisch Centrum Rotterdam Not yet recruiting
Rotterdam, Netherlands
University Medical Center Utrecht, Wilhelmina Kinderziekenhuis
Utrecht, Netherlands
Sponsors and Collaborators
Pharmaceutical Research Management srl
European Commission
Investigators
Principal Investigator: Saskia De Wildt, MD-PhD Erasmus Medical Center
More Information

Additional Information:
Publications:
Responsible Party: Pharmaceutical Research Management srl
ClinicalTrials.gov Identifier: NCT03275012     History of Changes
Other Study ID Numbers: GABA-2
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: September 7, 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
Morphine
Gabapentin
gamma-Aminobutyric Acid
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents