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The PALM Study (Palatability and Acceptability of Liquid Methotrexate)

  • Research type

    Research Study

  • Full title

    A Study of the Palatability and Acceptability of Liquid Methotrexate (The PALM Study)

  • IRAS ID

    187177

  • Contact name

    Hanna Lythgoe

  • Contact email

    hannalythgoe@doctors.org.uk

  • Sponsor organisation

    Alder Hey NHS Foundation Trust

  • Duration of Study in the UK

    2 years, 5 months, 28 days

  • Research summary

    Methotrexate is an important, effective treatment for children with a number of rheumatology conditions. Many patients do not tolerate methotrexate very well and have to be changed onto other medications which may have more long-term side effects. Recently, a new liquid formulation of methotrexate has been produced which is licensed for some oncology indications in children as well as some rheumatology conditions in adults. Children tell us that the previously used liquid ‘specials’ tasted bad. As far as we are aware no palatability testing has been done on the new liquid methotrexate formulation.

    This study looks at the palatability of the new liquid methotrexate. We will then compare the acceptability of the liquid methotrexate with methotrexate tablets. This information will allow us to better advise patients in the future.

    Participants will be children aged 4 – 17 years treated with oral methotrexate at Alder Hey Children’s Hospital by the rheumatology team. All patients will complete a taste test of the liquid formulation. If they consent they will be randomised to take either the liquid or the tablets for a 12 week period. A minimum of 40 patients will be recruited to the 12 week study. If they consent we will contact them again at six months to follow them up. Their medications will be managed by the clinical team and no changes will be made to their medications by taking part in this study.

    The primary outcome will be the palatability of liquid methotrexate on a visual analogue scale (VAS) for taste. Secondary outcomes will include difference in methotrexate intolerance and compliance between patients taking liquid or tablet methotrexate.

  • REC name

    Yorkshire & The Humber - Leeds West Research Ethics Committee

  • REC reference

    16/YH/0269

  • Date of REC Opinion

    11 Aug 2016

  • REC opinion

    Further Information Favourable Opinion