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

NCT03058224 | Completed

• 1 other identifier: IGN-ES001-CR01
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 23

Brief 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

Keywords

Pain, Symptom Severity; Immunoglobulin IgY; Fibromyalgia; Widespread Pain Index; Eggyolk; FIQ-R; SF-36v2TM; MOS-SS; FSS; PGIC; Quality of life

Outcome Measures

Primary Outcomes (3)

• Pain, final percent changes from baseline (based on diary), univariate analysis

  The overall pain improvement will be assessed by means of the percent changes from baseline (Visit 2) to end of treatment visit (Visit 9). Percent changes are preferred to raw changes due to their implicit adjustment for baseline differences in the case of proportional decrease. The baseline pain value will be calculated as mean overall pain of the last seven-day time period of the screening phase from Day -7 to Day -1. Minimum the last 6 out of 7 days prior to baseline visit V2 must be documented. The final pain value will be calculated as mean overall pain of the last seven-day time period prior to the end of the adjunctive treatment period from Day 36 to Day 42.

  Six Weeks

• Pain, final percent changes from baseline (based on diary), multivariate analysis

  In addition to the univariate analysis of the overall pain score, a correlation-sensitive multidimensional approach will be performed with respect to the two major pain activity levels: * Pain at rest (sum score of three locations), percent change from baseline * Pain perceived during physical strain (sum score of three locations), percent change from baseline

  Six Weeks

• Pain, final responder (based on diary)

  Responders will be defined as patients with a percent decrease from baseline of the overall pain score by at least 30%. This is a recommended benchmark for a "clinically meaningful improvement" (Farrar et al.), and provides robustness in case of proportional pain decrease (independency from baseline pain level). Tubach et al. (2012) defined a percent decrease of 20% as minimal clinically important change. Thus, the recommendation of Farrar et al. is regarded as optimum choice for a clinically meaningful responder definition.

  Six Weeks

Secondary Outcomes (8)

• Responder* rate, alternative definition (based on diary)

  Six Weeks

• Change in Fibromyalgia Impact Questionnaire Revised version (FIQ-R) score from baseline (visit V2)

  Six Weeks

• Change in Short-Form-36 version 2 Quality-of-Life questionnaire (SF-36v2TM) score from baseline (visit V2)

  Six Weeks

• Change in Medical Outcomes Study Sleep Scale (MOS-SS) score from baseline (visit V2)

  Six Weeks

• Change in Fatigue Severity Scale (FSS) score from baseline (visit V2)

  Six Weeks

Study Arms (2)

IGN-ES001

EXPERIMENTAL

Polyclonal avian immunoglobulin IgY containing specific IgY against E. coli F18ab and S. typhimurium in partially delipidated avian egg yolk powder

Drug: IGN-ES001; Drug: Parol 500 mg Tablets (acetaminophen)

Placebo

PLACEBO COMPARATOR

Polyclonal avian immunoglobulin IgY containing unspecific IgY in partially delipidated avian egg yolk powder

Drug: Parol 500 mg Tablets (acetaminophen)

Interventions

IGN-ES001 DRUG

Only active product will be compared with placebo as described in Arms and Interventions.

IGN-ES001

Parol 500 mg Tablets (acetaminophen) DRUG

Analgesic Rescue Medication

IGN-ES001; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female out-patient ≥ 18 years and ≤ 70 years of age.
• Patient willing and able (e.g. mental and physical condition) to participate in all aspects of the trial, including use of investigational product, subjective completion of diaries and questionnaires, attending scheduled visits, completing telephone interviews, and compliant with protocol requirements as evidenced by providing signed writteninformed consent.
• History of chronic widespread pain (for at least three months prior to visit V1 (screening)).
• a.) For FM patients: Widespread Pain Index (WPI) ≥ 7 and Symptom Severity (SS) ≥ 5 or WPI 3-6 and SS ≥ 9 (original preliminary fibromyalgia criteria of the American College of Rheumatology (ACR) 2010).
• b.) For non-FM CWP patients: WPI ≥ 3-6 and SS ≥ 5-8 (modified from the preliminary fibromyalgia criteria of the ACR 2010).

You may not qualify if:

• Patient has negative urine test at screening visit V1 for the following drugs of abuse:
• Amphetamine
• Cocaine
• Metamphetamine
• Morphine
• Tetrahydrocannabinol
• Female patient is surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or at least two years postmenopausal or, if of childbearing potential, she is sexually abstinent or agrees to practice adequate contraceptive measures (hormonal contraceptives, intrauterine device, double-barrier method).
• Patient must have completed at least 6 screening phase diary pages satisfactorily within the past 7 days before visit V2.
• Median pain NRS must be ≥ 4 in at least 1 out of the 6 pain qualities and ≥ 4 in overall pain assessment. The median will be calculated from the last 7 days before visit V2 (baseline) and will serve as baseline value.
• Patients without a basic and stable CWP therapy which started at least 30 days before V1 (screening) i.e. treatment-naive patients, first diagnosis.
• Known allergy or intolerance to egg or egg constituents.
• History of or currently active malignancy except for malignancies that were successfully treated and have had no recurrence within 5 years before screening visit V1.
• Known, uncontrolled endocrine disorders, such as hypothyroidism (TSH and free T4), and diabetes mellitus (HbA1c).
• Known severe hepatic, renal, respiratory, hematologic, neurologic, infectious, or immunologic disease, unstable cardiovascular disease, or any other medical or psychiatric condition that, in the judgment of the investigator, would make the patient inappropriate for participation in this trial.
• Immune response modulating medication/ therapy e.g. systemic corticosteroids, antibodies other than IP (investigational product) from a period starting 90 days before visit V1 (screening).

Sponsors & Collaborators

• IgNova GmbH: lead
• Scope International AG: collaborator
• Klinar CRO: collaborator
• CenTrial GmbH: collaborator
• Pharmasolutions4U: collaborator
• idv Data Analysis and Study Planning: collaborator

Study Sites (23)

Çukurova University School of Medicine

Adana, Turkey (Türkiye)

Location

Akdeniz University School of Medicine

Antalya, Turkey (Türkiye)

Location

Adnan Menderes University School of Medicine

Aydin, Turkey (Türkiye)

Location

Uludağ University School of Medicine

Bursa, Turkey (Türkiye)

Location

Onsekiz Mart University School of Medicine

Çanakkale, Turkey (Türkiye)

Location

Trakya University School of Medicine

Edirne, Turkey (Türkiye)

Location

Gaziantep University School of Medicine

Gaziantep, Turkey (Türkiye)

Location

Bezmialem Vakıf University School of Medicine

Istanbul, Turkey (Türkiye)

Location

İstanbul Physical Treatment and Rehabilitation Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

İstanbul University Cerrahpaşa School of Medicine

Istanbul, Turkey (Türkiye)

Location

İstanbul University İstanbul School of Medicine

Istanbul, Turkey (Türkiye)

Location

Maltepe University School of Medicine

Istanbul, Turkey (Türkiye)

Location

Marmara University Pendik Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

Şişli Florence Nighingale Hospital

Istanbul, Turkey (Türkiye)

Location

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

İzmir Medical Park Hospital

Izmir, Turkey (Türkiye)

Location

Erciyes UNiversity School of Medicine

Kayseri, Turkey (Türkiye)

Location

Necmettin Erbakan University School of Medicine

Konya, Turkey (Türkiye)

Location

Sakarya University School Of Medicine Korucuk Training and Research Hospital

Sakarya, Turkey (Türkiye)

Location

Cumhuriyet University School of Medicine

Sivas, Turkey (Türkiye)

Location

Namık Kemal University School of Medicine

Tekirdağ, Turkey (Türkiye)

Location

Karadeniz Technical University School of Medicine

Trabzon, Turkey (Türkiye)

Location

Bülent Ecevit University School of Medicine

Zonguldak, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia; Pain

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 20, 2017
• Study Start: February 16, 2017
• Primary Completion: November 30, 2017
• Study Completion: December 8, 2017
• Last Updated: August 7, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (23)