NCT03058224

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: IgNova GmbH · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Chronic Widespread Pain
• Fibromyalgia

Interventions

Type	Name	Description
DRUG	IGN-ES001	Only active product will be compared with placebo as described in Arms and Interventions.
DRUG	Parol 500 mg Tablets (acetaminophen)	Analgesic Rescue Medication

Timeline

• Start date: 2017-02-16
• Primary completion: 2017-11-30
• Completion: 2017-12-08
• First posted: 2017-02-20
• Last updated: 2018-08-07

Locations

23 sites across 1 country: Turkey (Türkiye)