Melatonin in patients with chronic pai

Phase 1

• Conditions: Sleep disturbance in patients with chronic pain; MedDRA version: 20.0Level: LLTClassification code 10040995Term: Sleep disturbanceSystem Organ Class: 100000004873; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2018-004048-50-GB
• Lead Sponsor: niversity of Aberdeen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-24
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria
Non-malignant pain of more than 3 months duration
Average pain intensity score of 7 or more on the Brief Pain Inventory numerical rating scale of 0 to 10
Age 18 or over
Stable, no expected change in medication during the trial (change in doses is allowed)
Normal liver function

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Exclusion criteria
Malignant pain
Pain score below 7
Pregnant or planning to become pregnant
Aged under 18
Hepatic enzyme activity above normal range
Concomitant treatment with nifedipine or fluvoxamine, benzodiazepines or hypnotics (zopilcone, zolpidem or zaleplon). History of drug/alcohol abuse, post-traumatic stress disorder or use of psychotropic medications
History of allergy to lactose
Insufficient English to understand trial information.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Does melatonin treatment improve sleep disturbance in patients with chronic pain?;Secondary Objective: Effect of melatonin (Circadin) vs placebo on pain score in patients with severe chronic pain<br><br>Effect of melatonin (Circadin) vs placebo on Actigraphy in patients with severe chronic pain<br><br>Melatonin and metabolite levels<br><br><br>Effect of melatonin (Circadin) vs placebo on psychomotor vigilance in patients with severe chronic pain<br><br>Effect of melatonin (Circadin) vs placebo on other sleep parameters in patients with severe chronic pain<br><br>Effect of melatonin on endogenous peptide levels in patients with severe chronic pain<br>;Primary end point(s): Difference in sleep disturbance between melatonin and placebo arms;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Sleep duration, sleep efficiency, sleep latency, sleep quality, Brief Pain Inventory pain scores, Actigraphy recorded pain scores and fatigue scores.;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment