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Efficacy and Safety of IGN-ES001 in Chronic Widespread Pain With or Without Fibromyalgia

Fibromyalgia Clinical Trial

Official title:
Randomized, Double-blind, Placebo-controlled Exploratory Trial to Investigate Efficacy and Safety of IGN-ES001 in Patients With Chronic Widespread Pain With or Without Fibromyalgia

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled exploratory trial to investigate efficacy and safety of food supplement IGN-ES001 in patients with chronic widespread pain (CWP) with or without fibromyalgia (FM).

Clinical Trial Description

Patients will perform five scheduled on-site visits and five phone calls:

- Screening visit, V1 (Day -10 to -7), informed consent

- Baseline visit, V2 (Day 1), randomization, treatment start

- Phone call, V3 (Day 4 ± 1)

- Phone call, V4 (Day 8 ± 3)

- Phone call, V5 (Day 15 ± 3)

- On-site visit, V6 (Day 22 ± 3)

- Phone call, V7 (Day 29 ± 3)

- Phone call, V8 (Day 36 ± 3)

- On-site visit, V9 (Day 43 + 3), treatment end

- Follow-up on-site visit, V10 (Day 50 + 7, or 7 + 7 days after EDV).

In addition, patients may be asked to return to the trial site between scheduled visits for assessment of safety data (unscheduled visits).

The maximum duration of treatment for the individual patient will be 46 days (including allowed visit window deviation). The maximum duration of trial participation for the individual patient will be 67 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03058224
Study type Interventional
Source IgNova GmbH
Contact
Status Completed
Phase N/A
Start date February 16, 2017
Completion date December 8, 2017
View Details
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