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Trial record 41 of 107 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

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

This study is currently recruiting participants.
Verified July 2017 by IgNova GmbH
Sponsor:
ClinicalTrials.gov Identifier:
NCT03058224
First Posted: February 20, 2017
Last Update Posted: July 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
SCOPE International AG
Klinar CRO
CenTrial GmbH
Pharmasolutions4U
idv Data Analysis and Study Planning
Information provided by (Responsible Party):
IgNova GmbH
  Purpose
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).

Condition Intervention
Chronic Widespread Pain Fibromyalgia Drug: IGN-ES001 Drug: Parol 500 mg Tablets (acetaminophen)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by IgNova GmbH:

Primary Outcome Measures:
  • Pain, final percent changes from baseline (based on diary), univariate analysis [ Time Frame: Six Weeks ]
    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.

  • Pain, final percent changes from baseline (based on diary), multivariate analysis [ Time Frame: Six Weeks ]

    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

  • Pain, final responder (based on diary) [ Time Frame: Six Weeks ]
    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.


Secondary Outcome Measures:
  • Responder* rate, alternative definition (based on diary) [ Time Frame: Six Weeks ]
  • Change in Fibromyalgia Impact Questionnaire Revised version (FIQ-R) score from baseline (visit V2) [ Time Frame: Six Weeks ]
  • Change in Short-Form-36 version 2 Quality-of-Life questionnaire (SF-36v2TM) score from baseline (visit V2) [ Time Frame: Six Weeks ]
  • Change in Medical Outcomes Study Sleep Scale (MOS-SS) score from baseline (visit V2) [ Time Frame: Six Weeks ]
  • Change in Fatigue Severity Scale (FSS) score from baseline (visit V2) [ Time Frame: Six Weeks ]
  • Patient's Global Impression of Change (PCIG) Questionnaire [ Time Frame: Six Weeks ]
    "The patients will rate their change in the overall status "since the start of the study, my overall status is" on a scale ranging from 1 (= very much improved) to 7 (= very much worse). Patients will complete the PGIC questionnaire at visit 9 (or at Early Discontinuation Visit) covering the whole 6-week treatment period from baseline visit 2."

  • Consumption of rescue medication [ Time Frame: Six Weeks ]
  • Time to first rescue medication (days) [ Time Frame: Dependent to the timeframe of the first rescue medication from first investigational product intake following baseline visit 2 through study completion, an average of six weeks ]

Estimated Enrollment: 230
Actual Study Start Date: February 16, 2017
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: IGN-ES001
Polyclonal avian immunoglobulin IgY containing specific IgY against E. coli F18ab and S. typhimurium in partially delipidated avian egg yolk powder
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
Placebo Comparator: Placebo
Polyclonal avian immunoglobulin IgY containing unspecific IgY in partially delipidated avian egg yolk powder
Drug: Parol 500 mg Tablets (acetaminophen)
Analgesic Rescue Medication

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

  5. Use of prior and concomitant medications/ therapies (if not excluded, see exclusion criteria no 6 and no 7), non-pharmacological therapies and lifestyle habits (e.g. diet changes, Ramadan participation, etc.) that could influence the efficacy assessments must have been stable for at least 30 days prior to visit V1 (screening) and are anticipated to be at a stable regimen throughout the trial until visit V9.
  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.

If all inclusion criteria are fulfilled (and none of the exclusion criteria below), the patient will be randomized at visit V2 and continues in the trial. Otherwise the patient will be excluded from trial participation.

Exclusion Criteria:

  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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03058224


Contacts
Contact: Gülden Ortaç +90 312 447 02 74 guldeno@klinar-cro.com

Locations
Turkey
Çukurova University School of Medicine Recruiting
Adana, Turkey
Contact: Rengin Güzel         
Akdeniz University School of Medicine Recruiting
Antalya, Turkey
Contact: Sibel Çubukçu Fırat         
Adnan Menderes University School of Medicine Recruiting
Aydın, Turkey
Contact: Ömer Faruk Şendur         
Uludağ University School of Medicine Recruiting
Bursa, Turkey
Contact: Jale İrdesel         
Trakya University School of Medicine Recruiting
Edirne, Turkey
Contact: Murat Birtane         
Gaziantep University School of Medicine Recruiting
Gaziantep, Turkey
Contact: Ali Gür         
Bezmialem Vakıf University School of Medicine Recruiting
Istanbul, Turkey
Contact: Aylin Rezvani         
İstanbul Physical Treatment and Rehabilitation Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Nur Kesiktaş         
İstanbul University Cerrahpaşa School of Medicine Recruiting
Istanbul, Turkey
Contact: Şansın Tüzün         
İstanbul University İstanbul School of Medicine Recruiting
Istanbul, Turkey
Contact: Dilşad Sindel         
Maltepe University School of Medicine Recruiting
Istanbul, Turkey
Contact: Nurdan Kotevoğlu         
Marmara University Pendik Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Gülseren Akyüz         
Şişli Florence Nighingale Hospital Recruiting
Istanbul, Turkey
Contact: Levent Öngönenel         
Şişli Hamidiye Etfal Training and Research Hospital Recruiting
Istanbul, Turkey
Contact: Jülide Öncü         
İzmir Medical Park Hospital Suspended
Izmir, Turkey
Erciyes UNiversity School of Medicine Recruiting
Kayseri, Turkey
Contact: Hüseyin Demir         
Necmettin Erbakan University School of Medicine Recruiting
Konya, Turkey
Contact: Hatice Uğurlu         
İnönü University School of Medicine Recruiting
Malatya, Turkey
Contact: Yüksel Ersoy         
Sakarya University School Of Medicine Korucuk Training and Research Hospital Recruiting
Sakarya, Turkey
Contact: Ayhan Kamanlı         
Cumhuriyet University School of Medicine Recruiting
Sivas, Turkey
Contact: Sami Hizmetli         
Namık Kemal University School of Medicine Recruiting
Tekirdag, Turkey
Contact: Ayşe Banu Sarıfakıoğlu         
Karadeniz Technical University School of Medicine Recruiting
Trabzon, Turkey
Contact: Murat Karkucak         
Bülent Ecevit University School of Medicine Recruiting
Zonguldak, Turkey
Contact: Selda Sarıkaya         
Onsekiz Mart University School of Medicine Recruiting
Çanakkale, Turkey
Contact: Coşkun Zateri         
Sponsors and Collaborators
IgNova GmbH
SCOPE International AG
Klinar CRO
CenTrial GmbH
Pharmasolutions4U
idv Data Analysis and Study Planning
  More Information

Responsible Party: IgNova GmbH
ClinicalTrials.gov Identifier: NCT03058224     History of Changes
Other Study ID Numbers: IGN-ES001-CR01
First Submitted: February 9, 2017
First Posted: February 20, 2017
Last Update Posted: July 5, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by IgNova GmbH:
Fibromyalgia
Pain, Symptom Severity
Immunoglobulin IgY
Widespread Pain Index
Eggyolk
FIQ-R
SF-36v2TM
MOS-SS
FSS
PGIC
Quality of life

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Immunoglobulins
Antibodies
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Immunologic Factors