Study to Compare Gabapentin to Tramadol in Children With Chronic Neuropathic or Mixed Pain

NCT02722603 | Terminated Phase 3 DMC

• 1 other identifier: 2014-004851-30
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Pain score

  Pain score (0-10) measured at baseline (before starting the therapy) and at the end of the treatment in: patients aged 3-24 months using FLACC pain scale, patients aged 3-7 years using FPS-R scale, patients aged 8-17 years using NRS-11. The FLACC (the Faces, Legs, Arms, Cry and Consolability) scale is composed by 5 categories. Each category is scored on the 0-2 scale, which results in a total score of 0-10, where 0=Relaxed and comfortable, 4-6=Moderate pain, 1-3=Mild discomfort, 7-10=Severe discomfort or pain or both. FPS-R (Faces Pain Scale - Revised - pts aged 3-7 years). Score is associated with face 0, 2, 4, 6, 8, or 10, where 0 = no pain and 10=very much pain. NRS-11 (Numerical Rating Scale - pts aged 8-17 years): numerical rating scale where 0=no pain and 10=worst possible pain.

  an average of 16 weeks

Secondary Outcomes (32)

• Percentage of responders to treatment

  an average of 16 weeks

• Daily pain intensity

  an average of 3 weeks

• Observational assessment of pain

  an average of 16 weeks

• Self-assessment of pain for children ≥8 years of age

  an average of 16 weeks

• Extent of pain

  an average of 16 weeks

Study Arms (2)

gabapentin / placebo tramadol

EXPERIMENTAL

gabapentin 75 mg/ml syrup / placebo tramadol, 3 times/day for 15 weeks.

Drug: gabapentin; Other: placebo tramadol

tramadol / placebo gabapentin

ACTIVE COMPARATOR

tramadol oral drops 100 mg/ml / placebo gabapentin, 3 times/day for 15 weeks.

Drug: tramadol; Other: placebo gabapentin

Interventions

gabapentin DRUG

75 mg/ml gabapentin syrup

gabapentin / placebo tramadol

tramadol DRUG

100 mg/ml tramadol oral drops

tramadol / placebo gabapentin

placebo tramadol OTHER

placebo tramadol oral drops

gabapentin / placebo tramadol

placebo gabapentin OTHER

placebo gabapentin syrup

tramadol / placebo gabapentin

Eligibility Criteria

• Age: 3 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, aged 3 months to less than 18 years at screening.
• Informed consent by parent(s) and/or legal guardian according to each country legal requirement.
• Assent by the patient, where applicable, according to each country legal requirement.
• Subjects that meet the diagnostic criteria for neuropathic or mixed pain.
• Subjects that present with chronic pain defined as the recurrent or continuous pain persisting more than 3 months. Duration of pain will be determined from the date of the first pain experienced.
• Subjects that present with at least moderate pain as defined by average pain intensity of ≥4/10 as assessed during a 3-day screening period
• Stable underlying disease condition and treatment.
• In presence of malignant diseases, subjects in clinical remission and/or no expected changes in their therapeutic protocol during participation to the present study.

You may not qualify if:

• 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.
• History of epileptic condition except febrile seizure disorder.
• Subjects with sleeping apnoea syndrome of any origin or subjects with history of severe respiratory impairment.
• Subjects with diagnosis of sickle cell disease.
• Subjects that present significant cognitive impairment.
• 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.
• Subjects with history of suicidal ideation or behaviour.
• History of substance abuse in particular opioids.
• Subjects under prohibited concomitant medication
• 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.
• Subjects born prematurely at ≤ 36 weeks gestational age, if recruited during the first year of age.
• Subjects with a body mass index (BMI) for age and gender of \< 5th percentile or \> 95th percentile.
• Subjects with glomerular filtration rate \< 90 mL/min/1.73 m2 (Schwarz equation).

Sponsors & Collaborators

• Pharmaceutical Research Management srl: lead
• European Commission: collaborator

Study Sites (2)

Universitaets klinikum Erlangen

Erlangen, Germany

Location

Erasmus Universitair Medisch Centrum Rotterdam

Rotterdam, Netherlands

Location

Related Publications (3)

• Finnerup NB, Sindrup SH, Jensen TS. Recent advances in pharmacological treatment of neuropathic pain. F1000 Med Rep. 2010 Jul 14;2:52. doi: 10.3410/M2-52.

  PMID: 21170362 BACKGROUND

• Mellegers MA, Furlan AD, Mailis A. Gabapentin for neuropathic pain: systematic review of controlled and uncontrolled literature. Clin J Pain. 2001 Dec;17(4):284-95. doi: 10.1097/00002508-200112000-00002.

  PMID: 11783808 BACKGROUND

• Kaguelidou F, Le Roux E, Mangiarini L, Lundin R, de Leeuw TG, Della Pasqua O, Felisi M, Bonifazi D, Tibboel D, Ceci A, de Wildt SN, Alberti C; GAPP consortium. Non-inferiority double-blind randomised controlled trial comparing gabapentin versus tramadol for the treatment of chronic neuropathic or mixed pain in children and adolescents: the GABA-1 trial-a study protocol. BMJ Open. 2019 Feb 20;9(2):e023296. doi: 10.1136/bmjopen-2018-023296.

  PMID: 30787078 DERIVED

MeSH Terms

Conditions

Chronic Pain

Interventions

Gabapentin; Tramadol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Officials

• Florentia Kaguelidou

  Center Clin Investig INSERM CIC 1426 H. R Debré APH de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 30, 2016
• Study Start: September 12, 2018
• Primary Completion: May 31, 2019
• Study Completion: June 18, 2019
• Last Updated: October 3, 2019

Record last verified: 2019-09

Locations

DE (1); NL (1)