Clinical trial • Not applicable • Other
Botulinum toxin type A for Post-surgical scar pain
Not applicable trial of Botulinum toxin type A for Post-surgical scar pain.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Post-surgical scar pain
- Trial Stage
- Not applicable
- Drug Modality
- Peptide/protein/enzyme|Small molecule
Key dates
- Initial CTIS Submission Date
- 24-11-2024
- First CTIS Authorization Date
- 05-12-2024
Trial design
Adcortyl™ Intra-articular / Intradermal Injection 10 mg/ml (triamcinolone acetonide); route intradermal; product marketing authorisation PA 0002/018/003; max total dose reported 50 mg. (No detailed dose schedule or administration frequency specified in the record.)-controlled Not applicable trial across 1 site in Ireland.
- Comparator
- Adcortyl™ Intra-articular / Intradermal Injection 10 mg/ml (triamcinolone acetonide); route intradermal; product marketing authorisation PA 0002/018/003; max total dose reported 50 mg. (No detailed dose schedule or administration frequency specified in the record.)
- Target Sample Size
- 60
Eligibility
Recruits 60 No vulnerable population selected. Written informed consent is required from participants. Pre-existing dementia is listed as an exclusion criterion "because of need to co-operate in completing questionnaires after the procedure.".
- Vulnerable Population
- No vulnerable population selected. Written informed consent is required from participants. Pre-existing dementia is listed as an exclusion criterion "because of need to co-operate in completing questionnaires after the procedure."
Inclusion criteria
- {"criterion_text":"- Male and Female patients over 18 years of age with a diagnosis of persistent post-surgical pain (pain lasting more than 3 months after the original surgical treatment) who attend the pain clinic outpatient department in MMUH that can provide written informed consent."}
Exclusion criteria
- {"criterion_text":"- Absence of informed written consent, pre-existing infection at block site, severe coagulopathy, allergy to local anaesthesia, pre-existing dementia [because of need to co-operate in completing questionnaires after the procedure]."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Numerical rating scale of pain (NRS)","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- b. Brief pain inventory score (short form) (BPI-sf) c. Pain self-efficacy questionnaire (PSEQ) d. Documentation of any adverse events e. Patients global impression of change (PGIC)","definition_or_measurement_approach":""}
Recruitment
- Planned Sample Size
- 60
- Recruitment Window Months
- 58
- Consent Approach
- Written informed consent required from participants (inclusion criterion: able to provide written informed consent). Subject information and informed consent form document is listed in the trial documents. No assent process or alternative consent procedures described.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 60
Ireland
- Earliest CTIS Part Ii Submission Date
- 24-11-2024
- Latest Decision Or Authorization Date
- 05-12-2024
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 60
Sites
- Site Name
- Mater Misericordiae University Hospital
- Department Name
- Pain Medicine
- Principal Investigator Name
- Conor Hearty
- Principal Investigator Email
- chearty@mater.ie
- Contact Person Name
- Conor Hearty
- Contact Person Email
- chearty@mater.ie
- Number Of Participants
- 60
Sponsor
Primary sponsor
- Full Name
- Mater Misericordiae University Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Ireland
Third parties
- {"country":"","full_name":"ABBVIE LIMITED","duties_or_roles":"Manufacturer/supplier of BOTOX (test product)","organisation_type":""}
- {"country":"","full_name":"BRISTOL-MYERS SQUIBB PHARMACEUTICALS UNLIMITED COMPANY","duties_or_roles":"Manufacturer/supplier of Adcortyl (comparator product)","organisation_type":""}
- {"country":"","full_name":"BAXTER HOLDING B.V.","duties_or_roles":"Manufacturer/supplier of Bupivacaine (auxiliary product)","organisation_type":""}
Investigational products
- Investigational Product Name
- BOTOX 100 Allergan Units Powder for Solution for Injection
- Active Substance
- Botulinum toxin type A
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Intradermal use
- Route
- Intradermal
- Authorisation Status
- Authorised (marketing authorisation PA 1824/17/1; authorisationCountryCode IE)
- Maximum Dose
- 100 IU
- Investigational Product Name
- Adcortyl™ Intra-articular / Intradermal Injection 10 mg/ml, Suspension for Injection, 5 ml
- Active Substance
- Triamcinolone acetonide
- Modality
- Small molecule
- Routes Of Administration
- Intradermal use
- Route
- Intradermal
- Authorisation Status
- Authorised (marketing authorisation PA 0002/018/003; authorisationCountryCode IE)
- Maximum Dose
- 50 mg
- Investigational Product Name
- Bupivacaine 2.5mg/ml Solution for Injection
- Active Substance
- Bupivacaine hydrochloride monohydrate
- Modality
- Small molecule
- Routes Of Administration
- Intradermal use
- Route
- Intradermal
- Authorisation Status
- Authorised (marketing authorisation PA 2299/035/001; authorisationCountryCode IE)
- Maximum Dose
- 50 mg (max total); max daily dose 25 mg
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