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MOCHA
NCT06476392Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2024
- Primary completion
- Mar 2026
- Countries
- 1
- Sponsor
- University Hospital Odense
- Modality
- Small Molecules
- Drugs
- melatonin
- Conditions
- chronic back pain
01
Overview
Phase 3, randomised, double-blind trial in chronic back pain comparing Melatonin with Placebo (2 arms). Primary endpoint: Difference in change in average pain intensity during the last 7 days at 6 weeks. Started Dec 2024; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Melatonin
Melatonin 10 mg once daily before bedtime
Placebo
Placebo once daily before bedtime
03
Who it enrols
Adults aged 18-64 with chronic back pain for at least 3 months, average pain intensity >= 4 on NRS, excluding those with opioid use, recent malignancies, severe psychiatric disorders, or contraindications to melatonin.
04
Endpoints
Primary
Difference in change in average pain intensity during the last 7 days
Secondary
Insomnia severity
Weekly pain intensity score trajectory
30% pain intensity responders
50% pain intensity responders
Global Perceived Effect for pain
Physical and Mental Health
Back pain related disability
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