Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
204
Countries
1
Sites
3
non-specific low back pain
To assess the efficacy of three months antibiotic treatment with amoxicillin compared to placebo for patients with chronic LBP and Modic type I changes on MRI.
Key facts
- Sponsor
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 17 Dec 2024 → ongoing
- Decision date (initial)
- 2024-10-18
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ZonMW
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacoeconomic
To assess the efficacy of three months antibiotic treatment with amoxicillin compared to placebo for patients with chronic LBP and Modic type I changes on MRI.
Secondary objectives 1
- To assess the cost-effectiveness of three months antibiotic treatment with amoxicillin compared to placebo for patients with chronic LBP and Modic type I changes on MRI.
Conditions and MedDRA coding
non-specific low back pain
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-515824-35-00 | Efficacy of antibiotic treatment for patients with chronic low back pain and Modic type I changes - randomized placebo-controlled trial | Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Aged 18-65 years.
- Chronic low back pain (i.e. duration >6 months) after a previous (MRI confirmed) disc herniation within the past 6 months to 2 years.
- At least 2 of the following questions should be answered with “Yes”: Does training and/or exercise increase your pain? Is your sleep during the night disturbed due to your back pain? Is it painful to turn over in bed at night? Do you suffer from morning pain?
- The mean pain intensity should be at least 5 points on a 0-10 NRS-scale, calculated as the mean pain intensity of 3 indices: current pain, worst pain within the preceding two weeks, and the usual mean pain within the preceding two weeks.
- Modic Type I changes visible on the MRI-scan in the vertebrae adjacent to the previous herniated disc.
Exclusion criteria 10
- Received antibiotic treatment in the past month.
- Current pregnancy, lactation or pregnancy-wish.
- Severe physical or psychiatric co-morbidities.
- LBP resulting from a specific cause such as a tumor or fracture.
- Surgery or epidural injection in the past 6 months.
- Previous antibiotic course of 100 days.
- Contra-indication for amoxicillin use: allergy to penicillins/amoxicillin, cephalosporin or carbapenem; mononucleosis; leukemia; phenylketonuria (PKU).
- Contra-indication for MRI.
- Current use of any of the following medications: allopurinol, methotrexate, phenylbutazone or probenecid.
- Hepatic or renal (eGFR≤30) impairment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pain and disability measured with the Roland Morris Disability Questionnaire (RMDQ)
Secondary endpoints 14
- LBP-intensity (0-10 NRS-scale)
- Leg pain intensity (0-10 NRS-scale)
- Global perceived effect (7-point Likert scale)
- Health-related quality of life (PROMIS-GH-10 and EQ-5D-5L)
- Self-reported number of days with sick leave
- Co-interventions (pharmacological and non-pharmacological)
- Patients’ satisfaction with treatment (7-point Likert scale)
- Success of blinding (patient and physician)
- Compliance (pill count)
- Pain self-efficacy (Pain Self-Efficacy Questionnaire)
- Sleep (Pittsburgh Sleep Quality Index)
- Neuropathic pain (PainDETECT)
- MRI-imaging at 12 months follow-up (to investigate the outcome of the antibiotic treatment on the Modic changes)
- LBP-related health care costs measured with cost questionnaires (iMCQ and iPCQ)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Amoxicillin 500 mg film-coated tablets
PRD10348401 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01CA04 — AMOXICILLIN
- Marketing authorisation
- PL 25298/0390
- MA holder
- BROWN & BURK UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo amoxicillin capsules 500mg
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Sponsor organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Address
- Dr. Molewaterplein 40
- City
- Rotterdam
- Postcode
- 3015 GD
- Country
- Netherlands
Scientific contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Prof. Bart Koes
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- Tamana Meihandoest
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 204 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-12-17 | 2025-04-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 14 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-515824-35 | 3 |
| Protocol (for publication) | D1_Protocol_2024-515824-35 - track changes | 3 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire T0 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire T2 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire T3 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire T4 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements - track changes | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment materials | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment materials - track changes | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amoxicilline capsules Mylan 500mg | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN_2024-515824-35 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL_2024-515824-35 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | Netherlands | Acceptable 2024-10-17
|
2024-10-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-04 | Netherlands | Acceptable 2025-07-31
|
2025-07-31 |