Analgesia and physiotherapy in children with cerebral palsy (ANTALKINECP)

Phase 1

• Conditions: Cerebral Palsy; MedDRA version: 18.1 Level: PT Classification code 10008129 Term: Cerebral palsy System Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Not possible to specify

• Registration Number: EUCTR2015-005538-23-FR
• Lead Sponsor: CHRU de Brest

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-02
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

• Cerebral palsy hemiplegic diplegic or tetraplegic spastic or not.
• Children who feel pain during the pre-screening physiotherapy session with a VAS score above 2 (or 1 on the FPS).
• Aged 6 to 17 years of both gender.
• Ability to express his/her pain and to measure its intensity with VAS or FPS.
• Informed and signed (parents, investigator and child if possible).

Are the trial subjects under 18? yes
Number of subjects for this age range: 180
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Lack of physiotherapy or frequency below every fortnight.
• Analgesic treatment already available or stopped in the last month.
• Severe infection or instable vital functions.
• Child unable to cooperate.
• Hypersensitivity to ibuprofen or any of the constituents in the product.
• History of allergy or asthma triggered by taking ibuprofen or substances of near activity such as other NSAIDs and aspirin.
• Allergy to other component of the capsule.
• Allergy or intolerance to lactose
• History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
• Active gastrointestinal ulcer.
• Severe hepatic failure.
• Severe renal failure.
• Uncontrolled severe cardiac failure.
• Systemic Lupus Erythematosus.
• Scheduled surgery procedure during or between the period of the assessment of pain
• Regular intake of ibuprofen

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified