Clinical trial • Musculoskeletal

Melatonin for Chronic low back pain

Clinical trial of Melatonin for Chronic low back pain.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Chronic low back pain
Drug Modality
Small molecule|Other

Key dates

Initial CTIS Submission Date
18-09-2024
First CTIS Authorization Date
15-01-2025

Trial design

Randomised, placebo (lactose monohydrate) as matching oral tablet; comparator arm: placebo administered once daily at bedtime for 6 weeks (matching melatonin schedule).-controlled trial across 1 site in Netherlands.

Randomised
Yes
Comparator
Placebo (Lactose monohydrate) as matching oral tablet; comparator arm: placebo administered once daily at bedtime for 6 weeks (matching melatonin schedule).
Target Sample Size
240
Trial Duration For Participant
42

Eligibility

Recruits 240 adults.

Inclusion criteria

  • {"criterion_text":"-Age 18 to 65"}
  • {"criterion_text":"-LBP for 3 months or longer"}
  • {"criterion_text":"-LBP must be present on most days within the past 3 months"}
  • {"criterion_text":"-LBP must limit life or work activities within the past 3 months"}
  • {"criterion_text":"-Average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days"}

Exclusion criteria

  • {"criterion_text":"-LBP resulting from a specific cause such as malignancy, fracture, lumbar radiculopathy and spinal stenosis"}
  • {"criterion_text":"-Radiating pain into the leg that goes further (down) than the knee"}
  • {"criterion_text":"-Inflammatory/autoimmune arthritis"}
  • {"criterion_text":"-Severe physical or psychiatric co-morbidities"}
  • {"criterion_text":"-Contraindications to melatonin"}

Endpoints

Primary endpoints

  • {"endpoint_text":"-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","definition_or_measurement_approach":"Change in average pain intensity (past 7 days) measured on a 0-10 Numeric Rating Scale (NRS) from baseline to 6 weeks."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
240
Recruitment Window Months
24
Consent Approach
Informed consent obtained from adult participants (18-65). Subject Information Sheet and Informed Consent Form for adults are provided (documents: L1_SIS and ICF adults). No assent procedures described (minors excluded).

Methods

  • General practices - recruitment materials for general practices (document titles include 'K2_Recruitment materials_general practices'), targeting patients with chronic low back pain in the Netherlands.
  • Social media - recruitment materials for social media (document title 'K2_Recruitment materials_social media'), targeting patients with chronic low back pain.

Geography

Total Number Of Sites
1
Total Number Of Participants
240

Netherlands

Earliest CTIS Part Ii Submission Date
18-12-2024
Latest Decision Or Authorization Date
15-01-2025
Processing Time Days
28
Number Of Sites
1
Number Of Participants
240

Sites

Site Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name
General practice
Principal Investigator Name
Bart Koes
Principal Investigator Email
secretariaat.onderzoek.hag@erasmusmc.nl
Contact Person Name
Bart Koes
Number Of Participants
240

Sponsor

Primary sponsor

Full Name
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Investigational products

Investigational Product Name
Lactose monohydrate
Modality
Other
Investigational Product Name
Melatonine Tiofarma 5 mg tabletten
Active Substance
Melatonin
Modality
Small molecule
Routes Of Administration
ORAL
Route
oral
Authorisation Status
Marketing authorisation RVG 120773 (Netherlands)
Starting Dose
10 mg
Dose Levels
10 mg
Frequency
once daily before bedtime
Maximum Dose
10 mg

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