Sleep disturbance in patients with chronic pain MedDRA version: 20.0 Level: LLT Classification code 10040995 Term: Sleep disturbance System Organ Class: 100000004873
Conditions
Interventions
Trade Name: Circadin
Product Name: Circadin
Pharmaceutical Form: Tablet
INN or Proposed INN: melatonin
CAS Number: 73-31-4
Other descriptive name: N-acetyl-5-methoxytryptamine
Concentration unit: mg m
Sponsors
University of Aberdeen
NHS Grampian
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Effect of melatonin (Circadin) vs placebo on Actigraphy in patients with severe chronic pain Melatonin and metabolite levels Effect of melatonin (Circadin) vs placebo on psychomotor vigilance in patients with severe chronic pain Effect of melatonin (Circadin) vs placebo on other sleep parameters in patients with severe chronic pain Effect of melatonin on endogenous peptide levels in patients with severe chronic pain ;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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Contacts
Public ContactProfessor /Co-investigator
University of Aberdeen
Outcome results
None listed