Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Ongoing, recruiting
Participants planned
195
Countries
1
Sites
6
Persistent Spinal Pain Syndrome Type II (PSPS T2)
The primary objective of the study is to examine whether there is a difference in disability 12 months after an intervention focusing on pain relief for axial pain in patients with chronic lower back pain after receiving a standardized pain medication tapering protocol before the intervention, a personalized pain medic…
Key facts
- Sponsor
- Vrije Universiteit Brussel
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 28 Jun 2023 → ongoing
- Decision date (initial)
- 2024-10-18
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516647-79-00
- EudraCT number
- 2022-003925-23
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The primary objective of the study is to examine whether there is a difference in disability 12 months after an intervention focusing on pain relief for axial pain in patients with chronic lower back pain after receiving a standardized pain medication tapering protocol before the intervention, a personalized pain medication tapering protocol before the intervention, or no pain medication tapering protocol before the intervention.
Conditions and MedDRA coding
Persistent Spinal Pain Syndrome Type II (PSPS T2)
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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 1
- 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 and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
Catapressan 150 microgrammes /1 ml solution injectable/solution pour perfusion
PRD8604607 · Product
- Active substance
- Clonidine Hydrochloride
- Substance synonyms
- N-(2,6-DICHLOROPHENYL)-4,5-DIHYDRO-1H-IMIDAZOL-2-AMINE HYDROCHLORIDE
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1200 µg microgram(s)
- Max total dose
- 5400 µg microgram(s)
- Max treatment duration
- 8 Day(s)
- Authorisation status
- Authorised
- ATC code
- C02AC01 — CLONIDINE
- Marketing authorisation
- BE021402
- MA holder
- GLENWOOD GMBH
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Suboxone 8 mg/2 mg sublingual tablets
PRD3489592 · Product
- Active substance
- Buprenorphine
- Pharmaceutical form
- SUBLINGUAL TABLET
- Route of administration
- ORAL
- Max daily dose
- 36 mg milligram(s)
- Max total dose
- 13062 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07BC51 — -
- Marketing authorisation
- EU/1/06/359/003
- MA holder
- INDIVIOR EUROPE LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
OxyNorm Instant 5 mg, comprimés orodispersibles
PRD1995099 · Product
- Active substance
- Oxycodone Hydrochloride
- Pharmaceutical form
- ORODISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA05 — OXYCODONE
- Marketing authorisation
- BE319067
- MA holder
- MUNDIPHARMA COMM VA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Catapressan 150 microgrammes comprimés
PRD8604618 · Product
- Active substance
- Clonidine Hydrochloride
- Substance synonyms
- N-(2,6-DICHLOROPHENYL)-4,5-DIHYDRO-1H-IMIDAZOL-2-AMINE HYDROCHLORIDE
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 11100 mg milligram(s)
- Max treatment duration
- 4 Month(s)
- Authorisation status
- Authorised
- ATC code
- C02AC01 — CLONIDINE
- Marketing authorisation
- BE021357
- MA holder
- GLENWOOD GMBH
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Libroxar 8 mg / 2 mg comprimés sublinguaux
PRD7627055 · Product
- Active substance
- Buprenorphine
- Pharmaceutical form
- SUBLINGUAL TABLET
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 36 mg milligram(s)
- Max total dose
- 13062 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07BC51 — -
- Marketing authorisation
- BE545297
- MA holder
- LABORATOIRES SMB S.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Suboxone 2 mg/0.5 mg sublingual tablets
PRD3489590 · Product
- Active substance
- Buprenorphine
- Pharmaceutical form
- SUBLINGUAL TABLET
- Route of administration
- ORAL
- Max daily dose
- 36 mg milligram(s)
- Max total dose
- 13062 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07BC51 — -
- Marketing authorisation
- EU/1/06/359/001
- MA holder
- INDIVIOR EUROPE LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
OxyNorm Instant 20 mg, comprimés orodispersibles
PRD1995100 · Product
- Active substance
- Oxycodone Hydrochloride
- Pharmaceutical form
- ORODISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA05 — OXYCODONE
- Marketing authorisation
- BE319085
- MA holder
- MUNDIPHARMA BV
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Libroxar 2 mg/0.5 mg Sublingualtabletten
PRD7627047 · Product
- Active substance
- Buprenorphine
- Pharmaceutical form
- SUBLINGUAL TABLET
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 36 mg milligram(s)
- Max total dose
- 13062 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- N07BC51 — -
- Marketing authorisation
- BE545280
- MA holder
- LABORATOIRES SMB S.A.
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
OxyNorm Instant 10 mg, comprimés orodispersibles
PRD1995098 · Product
- Active substance
- Oxycodone Hydrochloride
- Pharmaceutical form
- ORODISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- N02AA05 — OXYCODONE
- Marketing authorisation
- BE319076
- MA holder
- MUNDIPHARMA COMM VA
- MA country
- Belgium
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Vrije Universiteit Brussel
- Sponsor organisation
- Vrije Universiteit Brussel
- Address
- Laarbeeklaan 103
- City
- Jette
- Postcode
- 1090
- Country
- Belgium
Scientific contact point
- Organisation
- Vrije Universiteit Brussel
- Contact name
- Maarten Moens
Public contact point
- Organisation
- Vrije Universiteit Brussel
- Contact name
- PIANISSIMO
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 195 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
AZ ST-JAN Brugge A.V.
Pijnkliniek, Ruddershove 10, 8000, Brugge
Az Maria Middelares Gent
Department of Anesthesia, Intensive Care and Pain Medicine, Buitenring-Sint-Denijs 30, 9000, Gent
HeiligHartziekenhuis Lier
Algolier, Mechelsestraat 24, 2500, Lier
Algemeen Ziekenhuis Groeninge
Algologie, President Kennedylaan 4, 8500, Kortrijk
UZ Brussel
Neurosurgery, Laarbeeklaan 101, 1090, Jette
Algemeen Ziekenhuis Delta
Pijnkliniek, Deltalaan 1, 8800, Roeselare
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2023-06-28 | 2023-09-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 31 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol ENG 2024-516647-79-00_Redacted | 7 |
| Protocol (for publication) | D1_Protocol ENG 2024-516647-79-00_tc | 8 |
| Protocol (for publication) | D4_patient facing documents Brief huisarts_FR | 3 |
| Protocol (for publication) | D4_patient facing documents Brief huisarts_FR_tc | 2 |
| Protocol (for publication) | D4_patient facing documents Brief huisarts_NL | 2 |
| Protocol (for publication) | D4_patient facing documents Brief huisarts_NL_tc | 2 |
| Protocol (for publication) | D4_patient facing documents Contact onderzoeker_FR Redacted | 1 |
| Protocol (for publication) | D4_patient facing documents Contact onderzoeker_NL Redacted | 1 |
| Protocol (for publication) | D4_patient facing documents HE dagboek_FR | 2 |
| Protocol (for publication) | D4_patient facing documents HE dagboek_FR_tc | 2 |
| Protocol (for publication) | D4_patient facing documents HE dagboek_NL | 2 |
| Protocol (for publication) | D4_patient facing documents HE dagboek_NL_tc | 2 |
| Protocol (for publication) | D4_patient facing documents Recruitment flyer_FR | 1 |
| Protocol (for publication) | D4_patient facing documents Recruitment flyer_NL | 1 |
| Protocol (for publication) | D4_patient facing documents TaperbrochurePers_FR | 2 |
| Protocol (for publication) | D4_patient facing documents TaperbrochurePers_NL | 2 |
| Protocol (for publication) | D4_patient facing documents TaperbrochureStand_FR | 2 |
| Protocol (for publication) | D4_patient facing documents TaperbrochureStand_NL | 2 |
| Recruitment arrangements (for publication) | CTR_Transition_Statement | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_tc | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF FR Redacted | 6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF NL Redacted | 6 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Catapressan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Catapressan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Libroxar | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Libroxar | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC OxyNorm | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC OxyNorm | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Suboxone | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG 2024-514977-23-00 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Belgium | Acceptable 2024-10-17
|
2024-10-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-22 | Belgium | Acceptable 2025-03-05
|
2025-04-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-24 | Belgium | Acceptable with conditions 2025-09-01
|
2025-09-01 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-01-09 | Belgium | Acceptable 2026-02-13
|
2026-03-02 |