ow dose naltrexone for treatment of pain in patients with fibromyalgia

Phase 1

• Conditions: Pain in patients with fibromylagia; MedDRA version: 20.1Level: LLTClassification code 10049475Term: Chronic painSystem Organ Class: 100000004867; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2015-002972-26-DK
• Lead Sponsor: Smerteklinikken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-14
• Last Update Posted: 14 April 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

- > 18 years
- Fibromyalgi
- Patient in one of the involved pain centre in the study
- No inflammatory rheumatic pain condition
- Women - treatment with contrceptiva if not menopausal
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Cancer
- Treatment with opioids (other stable analgesic treatment 14 days before study start is allowed
- No change in stable analgesic treatment (p.n. paracetamol is allowed)
- Pregnant/breatfeeding
- Don´t speak danish
- Allergic to ingredient

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective is to investigate effect and mechanism of low dose naltrexone in the treatment of pain in patients with fibromyalgia;Secondary Objective: Secondary objectives:<br>- fatigue<br>- sleep problems<br>- activity level<br>- side effect of low dose naltrexone<br>- pain intensity in relation to experimental pain testing;Primary end point(s): Pain intensity<br>Functionality;Timepoint(s) of evaluation of this end point: End of trial

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - fatigue<br>- sleep problems<br>- activity level<br>- side effect of low dose naltrexone<br>- pain intensity in relation to experimental pain testing;Timepoint(s) of evaluation of this end point: End of trial