Overview
Sponsor-declared trial summary
Chronic low back pain
The aim of this randomized double-blind placebo-controlled clinical superiority trial is to investigate if daily treatment with melatonin 10mg once daily before bedtime for 6 weeks is superior compared with placebo in improving pain intensity assessed at 6 weeks after treatment initiation in patients with chronic LBP.
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
- 2 Mar 2025 → ongoing
- Decision date (initial)
- 2025-01-15
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
The aim of this randomized double-blind placebo-controlled clinical superiority trial is to investigate if daily treatment with melatonin 10mg once daily before bedtime for 6 weeks is superior compared with placebo in improving pain intensity assessed at 6 weeks after treatment initiation in patients with chronic LBP.
Conditions and MedDRA coding
Chronic low back pain
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age 18 to 65
- LBP for 3 months or longer
- LBP must be present on most days within the past 3 months
- LBP must limit life or work activities within the past 3 months
- Average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days
Exclusion criteria 5
- LBP resulting from a specific cause such as malignancy, fracture, lumbar radiculopathy and spinal stenosis
- Radiating pain into the leg that goes further (down) than the knee
- Inflammatory/autoimmune arthritis
- Severe physical or psychiatric co-morbidities
- Contraindications to melatonin
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The between-group difference in change in pain intensity (i.e. average pain intensity past 7 days) measured on a 0-10 NRS scale, from baseline to 6 weeks in patients with chronic LBP
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Melatonine Tiofarma 5 mg tabletten
PRD6823987 · Product
- Active substance
- Melatonin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 10 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- N05CH01 — -
- Marketing authorisation
- RVG 120773
- MA holder
- TIOFARMA BV
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
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
- B.W. Koes
Public contact point
- Organisation
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Contact name
- B.W. Koes
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 240 | 1 |
| 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 | 2025-03-02 | 2025-04-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-514769-20 | 3 |
| Protocol (for publication) | D1_Protocol_2024-514769-20_TC | 3 |
| Protocol (for publication) | D1_Protocol_2024-514769-20-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TC | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_general practices | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_general practices_TC | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_social media | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_social media_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_TC | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Melatonine tabletten Tiofarma 5mg | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN_2024-514769-20-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis NL_2024-514769-20-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-18 | Netherlands | Acceptable with conditions 2025-01-14
|
2025-01-15 |