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

NCT ID: NCT03058224

Last Updated: 2018-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-16
• Study Completion Date: 2017-12-08

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).

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IGN-ES001

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

Group Type: EXPERIMENTAL

IGN-ES001

Intervention Type: DRUG

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

Parol 500 mg Tablets (acetaminophen)

Intervention Type: DRUG

Analgesic Rescue Medication

Placebo

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

Group Type: PLACEBO_COMPARATOR

Parol 500 mg Tablets (acetaminophen)

Intervention Type: DRUG

Analgesic Rescue Medication

Interventions

IGN-ES001

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

Intervention Type: DRUG

Parol 500 mg Tablets (acetaminophen)

Analgesic Rescue Medication

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female out-patient ≥ 18 years and ≤ 70 years of age.

2. 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.

3. History of chronic widespread pain (for at least three months prior to visit V1 (screening)).

4. 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).

Exclusion Criteria

6. Patient has negative urine test at screening visit V1 for the following drugs of abuse:

1. Amphetamine

2. Cocaine

3. Metamphetamine

4. Morphine

5. Tetrahydrocannabinol

7. 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).

8. Patient must have completed at least 6 screening phase diary pages satisfactorily within the past 7 days before visit V2.

9. 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.

1. Patients without a basic and stable CWP therapy which started at least 30 days before V1 (screening) i.e. treatment-naive patients, first diagnosis.

2. Known allergy or intolerance to egg or egg constituents.

3. 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.

4. Known, uncontrolled endocrine disorders, such as hypothyroidism (TSH and free T4), and diabetes mellitus (HbA1c).

5. 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.

6. 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).

7. WHO step-II and step-III opioids (except occasional use of codeine as cough medication) from a period starting 60 days before visit V1 (screening).

8. Intractable vomiting likely to significantly influence gastrointestinal (GI) investigational product presence.

9. Surgery within 60 days before visit V1 (screening) or anticipated or scheduled for the next nine weeks after visit V1 (screening).

10. Vaccination from a period starting 30 days prior to visit V1 (screening).

11. Known liver disease or evidence of impaired hepatic function (total bilirubin, aspartate aminotransferase [ASAT], alanine transaminase [ALAT], gamma-glutamyltransferase [GGT], or alkaline phosphatase [AP] > 3 times the upper limit of normal).

12. Known kidney disease or evidence of impaired renal function, i.e. estimated glomerular filtration rate (eGFR) based on serum creatinine < 60 mL/min as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

13. Pregnancy or breastfeeding.

14. Known severe psychiatric illness (e.g. schizophrenia, major depression, anxiety disorder, obsessive compulsive disorder, panic disorder, social phobia, post-traumatic stress) or personality disorder (e.g. borderline personality). Obvious suicide risk.

15. Current and/ or history of known or suspected drug or substance abuse including alcohol abuse within five years before visit V1 (screening) as stated by the patient and/ or withdrawal symptoms.

16. Previous enrolment in this trial, or participation in any other studies involving investigational products, simultaneously or within six months prior to be screened for this trial (visit V1).

17. Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.

18. Employee of the investigator or trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or trial site, as well as family members of the employees or the investigators.

19. Patients unable or unwilling to include yoghurt or ayran into their daily diet.

20. Severe diarrhea.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scope International AG

INDUSTRY

Sponsor Role: collaborator

Klinar CRO

OTHER

Sponsor Role: collaborator

CenTrial GmbH

INDUSTRY

Sponsor Role: collaborator

Pharmasolutions4U

UNKNOWN

Sponsor Role: collaborator

idv Data Analysis and Study Planning

UNKNOWN

Sponsor Role: collaborator

IgNova GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Çukurova University School of Medicine

Adana, , Turkey (Türkiye)

Akdeniz University School of Medicine

Antalya, , Turkey (Türkiye)

Adnan Menderes University School of Medicine

Aydin, , Turkey (Türkiye)

Uludağ University School of Medicine

Bursa, , Turkey (Türkiye)

Onsekiz Mart University School of Medicine

Çanakkale, , Turkey (Türkiye)

Trakya University School of Medicine

Edirne, , Turkey (Türkiye)

Gaziantep University School of Medicine

Gaziantep, , Turkey (Türkiye)

Bezmialem Vakıf University School of Medicine

Istanbul, , Turkey (Türkiye)

İstanbul Physical Treatment and Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

İstanbul University Cerrahpaşa School of Medicine

Istanbul, , Turkey (Türkiye)

İstanbul University İstanbul School of Medicine

Istanbul, , Turkey (Türkiye)

Maltepe University School of Medicine

Istanbul, , Turkey (Türkiye)

Marmara University Pendik Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Şişli Florence Nighingale Hospital

Istanbul, , Turkey (Türkiye)

Şişli Hamidiye Etfal Training and Research Hospital

Istanbul, , Turkey (Türkiye)

İzmir Medical Park Hospital

Izmir, , Turkey (Türkiye)

Erciyes UNiversity School of Medicine

Kayseri, , Turkey (Türkiye)

Necmettin Erbakan University School of Medicine

Konya, , Turkey (Türkiye)

Sakarya University School Of Medicine Korucuk Training and Research Hospital

Sakarya, , Turkey (Türkiye)

Cumhuriyet University School of Medicine

Sivas, , Turkey (Türkiye)

Namık Kemal University School of Medicine

Tekirdağ, , Turkey (Türkiye)

Karadeniz Technical University School of Medicine

Trabzon, , Turkey (Türkiye)

Bülent Ecevit University School of Medicine

Zonguldak, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

IGN-ES001-CR01

Identifier Type: -

Identifier Source: org_study_id