RecruitingPhase 2ACTRN12614000540617

A pilot study to explore the safety of pyridostigmine in constipated palliative care patients

A pilot study of to assess the safety of pyridostigmine in palliative care patients already prescribed laxatives receiving medications that deliver an anticholinergic load and proven retention of more than 5 radiopaque markers


Sponsor

Calvary Mater Newcastle

Enrollment

10 participants

Start Date

Jul 4, 2014

Study Type

Interventional

Conditions

Summary

Constipation is a common, distressing and serious problem, affecting between 50-90% of people referred to specialist palliative care services. Approximately half of these people do not achieve adequate management of their constipation. The number of people who do not achieve satisfactory symptom relief is not acceptable. So the researchers conducting this study are looking to see if there are more effective ways to treat constipation. The aim of this study is to explore whether people who are currently taking anticholinergic medications and suffer from constipation, will respond better to a cholinergic agent (pyridostigmine), without affecting other symptoms.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Constipation is a very common and distressing problem for people receiving palliative care, affecting up to 90% of patients, and many do not get enough relief from standard laxatives. This study is testing whether a medication called pyridostigmine — which helps the gut move things along — can improve constipation in palliative care patients who are taking medications that slow the bowel. This is a safety study to see if the drug is well tolerated without making other symptoms worse. You may be eligible if: - You are 18 years of age or older - You are under the care of a specialist palliative care service - You are taking one or more medications known to cause constipation - You are dissatisfied with your current constipation management despite taking laxatives - You have a bowel function index score above 30 - Your doctor estimates you have enough time to participate in the study You may NOT be eligible if: - You have had a previous bad reaction to pyridostigmine - You have a history of bowel obstruction, irritable bowel syndrome, inflammatory bowel disease, or bowel surgery - You have faecal incontinence - You are pregnant or breastfeeding - You have severe kidney impairment, prolonged QT syndrome, asthma, epilepsy, hyperthyroidism, or myasthenia gravis - You have ischemic heart disease or a heart rhythm disorder within the past 12 months Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Oral pyridostigmine 60mg twice daily for seven days. The medicines for this study will be stored in the pharmacy prior to dispensing. The used bottles of medication will be collected at the complet

Oral pyridostigmine 60mg twice daily for seven days. The medicines for this study will be stored in the pharmacy prior to dispensing. The used bottles of medication will be collected at the completion of each participant to assess compliance. All unused study medicine will be destroyed on completion of study participation after the number of capsules remaining in the bottle has been counted.


Locations(2)

Calvary Mater Newcastle - Waratah

NSW, Australia

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

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ACTRN12614000540617


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