ULTRA Pain Study - Ursodeoxycholic acid in Low Phospholipid Associated Cholelithiasis (LPAC) Treating Recurrent Abdominal Pain Study
ULTRA Pain Study - Investigating the effectiveness of Ursodeoxycholic acid on Recurrent Abdominal Pain in adults with Low Phospholipid Associated Cholelithiasis (LPAC)
Melbourne Health
24 participants
May 10, 2022
Interventional
Conditions
Summary
Low Phospholipid Associated Cholelithiasis (LPAC) is a cause of post-operative pain and recurrent gallstones after gallbladder removal (cholecystectomy). This is a randomised control trial of a medication called ursodeoxycholic acid in patients with LPAC to prevent pain post gallbladder surgery, improve quality of life, reduce hospital presentations and patient use of strong narcotic painkillers. This trial is a crossover trial where participants will be randomised to undergo a 1 year experimental (ursodeoxycholic acid) or control arm (placebo). The experimental or control arm will be prescribed a daily dose of 10mg/kg of ursodeoxycholic acid or placebo. Participants will then undergo a 2 week washout period before crossing over to the opposite arm to complete the study. The dose will be prescribed at 10mg/kg daily and can be titrated to a maximum of 20mg/kg daily at the discretion of the treating clinician. The primary study outcome is number of episodes of biliary pain. Secondary outcomes include quality of life, hospitalisations, liver ultrasound findings.
Eligibility
Plain Language Summary
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Interventions
Ursodeoxycholic acid capsules orally starting at 10mg/kg daily with the ability to be increased to a maximum of 20mg/kg daily at the treating clinician's discretion if the participant is continuing to experience biliary pain. In the event of diarrhoea, ursodeoxycholic acid can be down titrated to 5mg/kg and slowly increased as tolerated. Cross-over trial design. Duration is for 1 year (52 weeks) each for ursodeoxycholic acid and placebo. The wash out period is 2 weeks. Adherence is monitored by the Clinical Trials Pharmacy Department who will monitor unused capsules.
Locations(1)
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ACTRN12621000450819