Clinical trial • Phase IV • Musculoskeletal
Clonidine hydrochloride for Persistent spinal pain syndrome type II (PSPS T2)
Phase IV trial of Clonidine hydrochloride for Persistent spinal pain syndrome type II (PSPS T2).
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Persistent spinal pain syndrome type II (PSPS T2)
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-10-2024
- First CTIS Authorization Date
- 18-10-2024
Trial design
Three arms: a standardized pain medication tapering protocol before the intervention; a personalized pain medication tapering protocol before the intervention; no pain medication tapering protocol before the intervention (control). Phase IV trial in Belgium.
- Comparator
- Three arms: a standardized pain medication tapering protocol before the intervention; a personalized pain medication tapering protocol before the intervention; no pain medication tapering protocol before the intervention (control).
- Target Sample Size
- 195
- Trial Duration For Participant
- 365
Eligibility
Recruits 195 No vulnerable population selected; participants must be 18 years or older; informed consent to be obtained from the participant. Subject information and informed consent forms are available in Dutch and French..
- Vulnerable Population
- No vulnerable population selected; participants must be 18 years or older; informed consent to be obtained from the participant. Subject information and informed consent forms are available in Dutch and French.
Inclusion criteria
- {"criterion_text":"-Patients being diagnosed with chronic lower back pain, defined as patients with lower back pain for more than three months. Patients need to be scheduled for a non-pharmacological intervention focusing on pain relief axial problems (such as spinal cord stimulation, dorsal root ganglion stimulation, radiofrequency ablation, infiltrations, epidural injections, nerve blocks, revalidation or kinesitherapy, psychological treatments (such as pain education, cognitive behavioural therapy, mindfulness, and acceptance and commitment therapy), or adjunctive therapies) to be eligible for participation in the study. Moreover, patients must be 18 years or older, taking opioids, and be able to speak and read Dutch or French."}
Exclusion criteria
- {"criterion_text":"-Exclusion criteria include the following: Being actively treated for cancer, Having a life expectancy below 6 months, Receiving intrathecal drug delivery, Having contraindications for Clonidine (e.g., known hypotension which requires medication) or for Buprenorphine/Naloxone (e.g., severe respiratory insufficiency, hepatic insufficiency), Having epilepsy currently treated by Pregabalin, Currently using benzodiazepines at doses more than 40 mg diazepam-equivalents per day."}
Endpoints
Primary endpoints
- {"endpoint_text":"-The primary endpoint is to observe whether there is a difference in the ODI score in patients with chronic lower back pain 12 months after an intervention focusing on pain relief for axial problems between the three arms. A longitudinal mixed model analysis will be used with timepoints defined at baseline, 1 month, 3 months, 6 months, and 12 months after the intervention.","definition_or_measurement_approach":"ODI score measured at baseline, 1 month, 3 months, 6 months and 12 months after the intervention; analysis using a longitudinal mixed model comparing the three arms."}
Recruitment
- Planned Sample Size
- 195
- Recruitment Window Months
- 39
- Consent Approach
- Informed consent obtained from each participant (participants must be ≥18 years). Subject information and informed consent forms available in Dutch and French (L1_SIS and ICF NL and FR documents listed).
Methods
- Recruitment flyers (Recruitment flyer_NL, Recruitment flyer_FR) targeting patients with chronic low back pain (Belgium).
- Letter to general practitioners (Brief huisarts_NL, Brief huisarts_FR) to inform GPs about the study and refer eligible patients (Belgium).
- Patient-facing contact documents (Contact onderzoeker_NL, Contact onderzoeker_FR) providing researcher contact details for interested participants (Belgium).
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 195
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-08-2024
- Latest Decision Or Authorization Date
- 02-03-2026
- Processing Time Days
- 570
- Number Of Sites
- 6
- Number Of Participants
- 195
Sites
- Site Name
- AZ ST-JAN Brugge A.V.
- Department Name
- Pijnkliniek
- Principal Investigator Name
- Ophélie Vandemoortele
- Principal Investigator Email
- pijnkliniek@azsintjan.be
- Contact Person Name
- Ophélie Vandemoortele
- Contact Person Email
- pijnkliniek@azsintjan.be
- Site Name
- HeiligHartziekenhuis Lier
- Department Name
- Algolier
- Principal Investigator Name
- Laura Verschueren
- Principal Investigator Email
- pianissimo@vub.be
- Contact Person Name
- Laura Verschueren
- Contact Person Email
- pianissimo@vub.be
- Site Name
- Az Maria Middelares Gent
- Department Name
- Department of Anesthesia, Intensive Care and Pain Medicine
- Principal Investigator Name
- Wout Van Oosterwyck
- Principal Investigator Email
- pianissimo@vub.be
- Contact Person Name
- Wout Van Oosterwyck
- Contact Person Email
- pianissimo@vub.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Pijnkliniek
- Principal Investigator Name
- Billet Bart
- Principal Investigator Email
- pianissimo@vub.be
- Contact Person Name
- Billet Bart
- Contact Person Email
- pianissimo@vub.be
- Site Name
- Algemeen Ziekenhuis Groeninge
- Department Name
- Algologie
- Principal Investigator Name
- Pieter Jan Germonpré
- Principal Investigator Email
- pianissimo@vub.be
- Contact Person Name
- Pieter Jan Germonpré
- Contact Person Email
- pianissimo@vub.be
- Site Name
- UZ Brussel
- Department Name
- Neurosurgery
- Principal Investigator Name
- Maarten Moens
- Principal Investigator Email
- pianissimo@vub.be
- Contact Person Name
- Maarten Moens
- Contact Person Email
- pianissimo@vub.be
Sponsor
Primary sponsor
- Full Name
- Vrije Universiteit Brussel
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Belgium
Investigational products
- Investigational Product Name
- Catapressan 150 microgrammes /1 ml solution injectable/solution pour perfusion
- Active Substance
- Clonidine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Intravenous
- Route
- Intravenous
- Authorisation Status
- Authorised
- Maximum Dose
- 1200 µg/day
- Investigational Product Name
- Catapressan 150 microgrammes comprimés
- Active Substance
- Clonidine hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 600 mg/day
- Investigational Product Name
- Suboxone 8 mg/2 mg sublingual tablets
- Active Substance
- Buprenorphine; Naloxone
- Modality
- Small molecule
- Routes Of Administration
- Oral (sublingual)
- Route
- Sublingual
- Authorisation Status
- Authorised
- Maximum Dose
- 36 mg/day
- Investigational Product Name
- Suboxone 2 mg/0.5 mg sublingual tablets
- Active Substance
- Buprenorphine; Naloxone
- Modality
- Small molecule
- Routes Of Administration
- Oral (sublingual)
- Route
- Sublingual
- Authorisation Status
- Authorised
- Maximum Dose
- 36 mg/day
- Investigational Product Name
- Libroxar 8 mg / 2 mg comprimés sublinguaux
- Active Substance
- Buprenorphine; Naloxone
- Modality
- Small molecule
- Routes Of Administration
- Sublingual
- Route
- Sublingual
- Authorisation Status
- Authorised
- Maximum Dose
- 36 mg/day
- Investigational Product Name
- Libroxar 2 mg/0.5 mg Sublingualtabletten
- Active Substance
- Buprenorphine; Naloxone
- Modality
- Small molecule
- Routes Of Administration
- Sublingual
- Route
- Sublingual
- Authorisation Status
- Authorised
- Maximum Dose
- 36 mg/day
- Investigational Product Name
- OxyNorm Instant 5 mg, comprimés orodispersibles
- Active Substance
- Oxycodone hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 80 mg/day
- Investigational Product Name
- OxyNorm Instant 10 mg, comprimés orodispersibles
- Active Substance
- Oxycodone hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 80 mg/day
- Investigational Product Name
- OxyNorm Instant 20 mg, comprimés orodispersibles
- Active Substance
- Oxycodone hydrochloride
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised
- Maximum Dose
- 80 mg/day
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