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
Calvary Mater Newcastle
10 participants
Jul 4, 2014
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
Inclusion Criteria8
- Age >18;
- English speaking;
- Person under the care of a specialist palliative care service receiving medications that are associated with an anti-cholinergic effects based on the Clinician–Rated Anti-cholinergic Drug scale;
- Self-assessed as dissatisfied with current experiences of constipation despite receiving laxatives;
- A score of more than 30 on the self-reported three-item Bowel Function Index;
- An estimated prognosis in the opinion of the treating physician that is sufficient to allow the person to participate in the study;
- The person themselves is willing and able to participate;
- An intact gastrointestinal system.
Exclusion Criteria17
- Previous adverse reaction to pyridostigmine;
- Past history of bowel obstructions, strictures or history of any diseases affecting bowel transit (e.g. ileus, uncontrolled hypothyroidism, hypercalcaemia), irritable bowel syndrome (IBS), inflammatory bowel disease (ulcerative colitis, Crohn’s disease), history of faecal incontinence or bowel resection);
- Diagnosed pelvic disorders that may be a cause of constipation;
- Surgery (except for minor procedures) within 60 days of Screening, or planned surgery during study treatment that would influence pain or bowel function or preclude completion of the study;
- History of chronic constipation prior to enrolling with palliative care services;
- Currently pregnant or planning to become pregnant or breastfeeding;
- Faecal impaction (based on a rectal exam);
- Prolonged QT syndrome (greater than 0.43sec for males, 0.45 for females)
- Medications that are prescribed directly for their anti-cholinergic effects (e.g. Glycopyrrolate for drooling; amitriptyline for loose bowel actions);
- Creatinine clearance of < 30 ml/min;
- Thrombocytopenia of <50,000 platelets per microlitre precluding rectal interventions
- Neutropaenia of <2x109/L
- Asthma requiring regular medications;
- Ischaemic heart disease or cardiac arrhythmias within the previous 12 months;
- Epilepsy requiring medication;
- Hyperthyroidism;
- Myasthenia gravis treated with pyridostigmine
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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 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)
View Full Details on ANZCTR
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ACTRN12614000540617