Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000254897p
Ethics application status
Not yet submitted
Date submitted
17/12/2020
Date registered
10/03/2021
Date last updated
10/03/2021
Date data sharing statement initially provided
10/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of oral pyridostigmine for the treatment of acute colonic pseudo-obstruction - a prospective, randomized, placebo-controlled trial.
Scientific title
Efficacy of oral pyridostigmine for the treatment of acute colonic pseudo-obstruction in adults - a prospective, randomized, placebo-controlled trial.
Secondary ID [1] 303040 0
None
Universal Trial Number (UTN)
Trial acronym
OPPS-1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute colonic pseudo-obstruction 320108 0
Condition category
Condition code
Oral and Gastrointestinal 318049 318049 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral pyridostigmine 10mg two times a day for up to 48 hours or until bowels open, whichever earlier. Medication will be administered by nursing staff on the wards, as the trial participants will be current inpatients. Inpatient medical records will provide evidence of medication administration.
Intervention code [1] 319329 0
Treatment: Drugs
Comparator / control treatment
Placebo-controlled (glucose capsule).
Control group
Placebo

Outcomes
Primary outcome [1] 326036 0
Passage of bowel motions, as sighted and documented on stool chart by ward nursing staff.
Timepoint [1] 326036 0
48 hours post commencement of intervention.
Secondary outcome [1] 389939 0
Time to passage of flatus, as reported by the patient, to the ward nursing staff.
Timepoint [1] 389939 0
48 hours post commencement of intervention.

Eligibility
Key inclusion criteria
Adult patients with acute colonic pseudo-obstruction confirmed on imaging (plain abdominal radiograph, computed tomography, or magnetic resonance imaging) in whom a distal colonic obstruction has been ruled out via a rigid sigmoidoscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with known adverse reaction to pyridostigmine.
Patients with signs of abdominal peritonism.
Patients currently already on oral pyridostigmine.
Patients

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Via sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using a randomization table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
Date of last participant enrolment
Anticipated
17/01/2022
Actual
Date of last data collection
Anticipated
28/02/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18234 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 18235 0
Maroondah Hospital - Ringwood East
Recruitment hospital [3] 18236 0
Angliss Hospital - Upper Ferntree Gully
Recruitment postcode(s) [1] 32298 0
3128 - Box Hill
Recruitment postcode(s) [2] 32299 0
3135 - Ringwood East
Recruitment postcode(s) [3] 32300 0
3156 - Upper Ferntree Gully

Funding & Sponsors
Funding source category [1] 307452 0
Charities/Societies/Foundations
Name [1] 307452 0
Eastern Health Foundation
Country [1] 307452 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health - Box Hill Hospital
Address
5 Arnold Street
Box Hill 3128
Victoria
Country
Australia
Secondary sponsor category [1] 308125 0
None
Name [1] 308125 0
Address [1] 308125 0
Country [1] 308125 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 307530 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 307530 0
Level 2
5 Arnold Street
Box Hill 3128
Victoria
Ethics committee country [1] 307530 0
Australia
Date submitted for ethics approval [1] 307530 0
31/03/2021
Approval date [1] 307530 0
Ethics approval number [1] 307530 0

Summary
Brief summary
This trial aims to investigate the efficacy of oral pyridostigmine, a medication currently used to treat Myasthenia Gravis, in the treatment of acute colonic pseudo-obstruction (ACPO). Acute colonic pseudo-obstruction occurs when the large intestine becomes dilated in the absence of downstream mechanical obstruction, and often occurs in the setting of hospitalized patients who are non-mobile, and/or are on significant amounts of opioid medications. Current treatment options for ACPO include the use of medications such as intravenous neostigmine, which is effective but requires cardiac monitoring due to the risk of cardiac arrhythmias, endoscopic decompression, or surgery. A recently published case series has suggested that oral pyridostigmine is effective in treating patients with ACPO, without the need for cardiac monitoring, unlike neostigmine. However, strong evidence in this field is still lacking, which this study aims to help address.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107562 0
Dr Jonathan Chua
Address 107562 0
Eastern Health
Box Hill Hospital
5 Arnold Street
Box Hill 3128 Victoria
Country 107562 0
Australia
Phone 107562 0
+61 403647567
Fax 107562 0
Email 107562 0
[email protected]
Contact person for public queries
Name 107563 0
Dr Jonathan Chua
Address 107563 0
Eastern Health
5 Box Hill Hospital
Arnold Street
Box Hill 3128 Victoria
Country 107563 0
Australia
Phone 107563 0
+61 403647567
Fax 107563 0
Email 107563 0
[email protected]
Contact person for scientific queries
Name 107564 0
Dr Jonathan Chua
Address 107564 0
Eastern Health
Box Hill Hospital
5 Arnold Street
Box Hill 3128 Victoria
Country 107564 0
Australia
Phone 107564 0
+61 403647567
Fax 107564 0
Email 107564 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient demographics, comorbidity count, control or intervention group, primary outcome, adverse events.
When will data be available (start and end dates)?
28/02/2022 - 1 March 2026
Available to whom?
De-identified data will be made available to clinical researchers upon request.
Available for what types of analyses?
To achieve the aim of the study, and potential meta-analyses in the future within the proposed timeframe.
How or where can data be obtained?
Access subject to approval from the principal investigator:
Dr Jonathan Chua
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.