E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10008129 |
E.1.2 | Term | Cerebral palsy |
E.1.2 | System Organ Class | 10010331 - Congenital, familial and genetic disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main objective of this study is to evaluate the effectiveness of ibuprofen versus placebo on the pain caused by physical therapy in children with cerebral palsy evaluated by reducing the score of visual analogue scale (VAS) |
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E.2.2 | Secondary objectives of the trial |
• Assess the safety and side effects of ibuprofen administered as a single daily preventive dose.
• Determine whether the pain medication given prior to the physiotherapy session:
- Decreases anxiety assessed by VAS before the physiotherapy session.
- Decreases at the end of treatment period:
o anxiety assessed by the Yale preoperative anxiety scale.
o the overall perception of the pain during the week before assessed by the pain section of Child health questionnaire.
o spasticity of four members assessed by the score Ashworth scale.
- Increases the ability of muscle to be stretched at the end of the treatment period evaluated by measuring joint angles with a goniometer. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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).
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Reduction of at least 20% of the average VAS between the run-in phase and the treatment phase (placebo and ibuprofen). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
A the end of the study ( 20 physiotherapy session) |
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E.5.2 | Secondary end point(s) |
Other criteria will be subject to statistical analysis and if necessary a subgroup analysis. Will be considered as secondary endpoints:
•The pain reduction assessed by the Child health questionnaire.
•The anxiety reduction assessed by a VAS and the Yale preoperative anxiety scale.
•The increase in quality of life assessed by the CP Child.
•The incidence of adverse events.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
A the end of the study ( 20 physiotherapy session) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject undergoing the trial |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |