Chronic Widespread PainNCT03058224
Efficacy and Safety of IGN-ES001 in Chronic Widespread Pain With or Without Fibromyalgia
A study testing IGN-ES001 and Parol 500 mg Tablets (acetaminophen) in people with Chronic Widespread Pain and Fibromyalgia, run by IgNova GmbH at 23 sites in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Widespread Pain, Fibromyalgia
- What is being tested?
- IGN-ES001 and Parol 500 mg Tablets (acetaminophen)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 23 sitesTurkey (Türkiye)
- Study dates
- 16 Feb 2017to 8 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- 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.
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- 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.
- 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.
Who cannot join
- 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).
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- 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).
- Intractable vomiting likely to significantly influence gastrointestinal (GI) investigational product presence.
- Surgery within 60 days before visit V1 (screening) or anticipated or scheduled for the next nine weeks after visit V1 (screening).
- Vaccination from a period starting 30 days prior to visit V1 (screening).
- 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).
- 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.
- Pregnancy or breastfeeding.
- 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.
- 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.
- 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).
- Persons committed to an institution by virtue of an order issued either by the judicial or other authorities.
- 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.
- Patients unable or unwilling to include yoghurt or ayran into their daily diet.
- Severe diarrhea.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Turkey (Türkiye)23 sites
Çukurova University School of Medicine
Adana
Akdeniz University School of Medicine
Antalya
Adnan Menderes University School of Medicine
Aydin
Uludağ University School of Medicine
Bursa
Onsekiz Mart University School of Medicine
Çanakkale
Trakya University School of Medicine
Edirne
Gaziantep University School of Medicine
Gaziantep
Bezmialem Vakıf University School of Medicine
Istanbul
İstanbul Physical Treatment and Rehabilitation Training and Research Hospital
Istanbul
İstanbul University Cerrahpaşa School of Medicine
Istanbul
İstanbul University İstanbul School of Medicine
Istanbul
Maltepe University School of Medicine
Istanbul
Marmara University Pendik Training and Research Hospital
Istanbul
Şişli Florence Nighingale Hospital
Istanbul
Şişli Hamidiye Etfal Training and Research Hospital
Istanbul
İzmir Medical Park Hospital
Izmir
Erciyes UNiversity School of Medicine
Kayseri
Necmettin Erbakan University School of Medicine
Konya
Sakarya University School Of Medicine Korucuk Training and Research Hospital
Sakarya
Cumhuriyet University School of Medicine
Sivas
Namık Kemal University School of Medicine
Tekirdağ
Karadeniz Technical University School of Medicine
Trabzon
Bülent Ecevit University School of Medicine
Zonguldak
About this study
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
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).
Read the 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
- Being tested
- IGN-ES001, Parol 500 mg Tablets (acetaminophen)
- Keywords
- Pain, Symptom Severity, Immunoglobulin IgY, Fibromyalgia, Widespread Pain Index, Eggyolk, FIQ-R, SF-36v2TM, MOS-SS, FSS, PGIC, Quality of life
- Medical subject headings
- Chronic Pain, Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGN-ES001Drug
Only active product will be compared with placebo as described in Arms and Interventions.
Parol 500 mg Tablets (acetaminophen)Drug
Analgesic Rescue Medication
| Study group | Role | What they receive |
|---|---|---|
| IGN-ES001 | Experimental | Polyclonal avian immunoglobulin IgY containing specific IgY against E. coli F18ab and S. typhimurium in partially delipidated avian egg yolk powder Receives: 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 Receives: Drug: Parol 500 mg Tablets (acetaminophen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: Six Weeks
Secondary outcomes (8)
Responder* rate, alternative definition (based on diary)
Measured: Six Weeks
Change in Fibromyalgia Impact Questionnaire Revised version (FIQ-R) score from baseline (visit V2)
Measured: Six Weeks
Change in Short-Form-36 version 2 Quality-of-Life questionnaire (SF-36v2TM) score from baseline (visit V2)
Measured: Six Weeks
Change in Medical Outcomes Study Sleep Scale (MOS-SS) score from baseline (visit V2)
Measured: Six Weeks
Change in Fatigue Severity Scale (FSS) score from baseline (visit V2)
Measured: Six Weeks
Patient's Global Impression of Change (PCIG) Questionnaire
"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."
Measured: Six Weeks
Consumption of rescue medication
Measured: Six Weeks
Time to first rescue medication (days)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start16 Feb 2017
- Primary completion30 Nov 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Widespread PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- IgNova GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Scope International AG, Klinar CRO, CenTrial GmbH, Pharmasolutions4U, idv Data Analysis and Study Planning
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03058224
- Sponsor's protocol ID
- IGN-ES001-CR01
- Status last verified
- Aug 2018
- First submitted
- 9 Feb 2017
- Last updated
- 7 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03058224
- Acronym / sponsor ID
- IGN-ES001-CR01
- Conditions
- Chronic Widespread Pain, Fibromyalgia
- Keywords
- Pain, Symptom Severity, Immunoglobulin IgY, Fibromyalgia, Widespread Pain Index, Eggyolk, FIQ-R, SF-36v2TM, MOS-SS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- IgNova GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Scope International AG, Klinar CRO, CenTrial GmbH, Pharmasolutions4U, idv Data Analysis and Study Planning
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IGN-ES001 | Experimental | Drug: IGN-ES001, Drug: Parol 500 mg Tablets (acetaminophen)Polyclonal avian immunoglobulin IgY containing specific IgY against E. coli F18ab and S. typhimurium in partially delipidated avian egg yolk powder |
| Placebo | Placebo comparator | Drug: Parol 500 mg Tablets (acetaminophen)Polyclonal avian immunoglobulin IgY containing unspecific IgY in partially delipidated avian egg yolk powder |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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).
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGN-ES001Only active product will be compared with placebo as described in Arms and Interventions. | Drug | IGN-ES001 |
| Parol 500 mg Tablets (acetaminophen)Analgesic Rescue Medication | Drug | IGN-ES001, Placebo |
Primary outcome
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.
8 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGN-ES001 and Parol 500 mg Tablets (acetaminophen) in people with Chronic Widespread Pain and Fibromyalgia, run by IgNova GmbH at 23 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain, final percent changes from baseline (based on diary), univariate analysis (time frame: Six Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2018.