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

NCT03058224 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2018-08-07

No results posted yet for this study

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).

Conditions

  • Chronic Widespread Pain
  • Fibromyalgia

Interventions

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

Sponsors & Collaborators

  • Scope International AG

    collaborator INDUSTRY

  • Klinar CRO

    collaborator OTHER

  • CenTrial GmbH

    collaborator INDUSTRY

  • Pharmasolutions4U

    collaborator UNKNOWN

  • idv Data Analysis and Study Planning

    collaborator UNKNOWN

  • IgNova GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-16
Primary Completion
2017-11-30
Completion
2017-12-08

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03058224 on ClinicalTrials.gov