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
Overview
- Phase
- N/A
- Intervention
- IGN-ES001
- Conditions
- Chronic Widespread Pain
- Sponsor
- IgNova GmbH
- Enrollment
- 230
- Locations
- 23
- Primary Endpoint
- Pain, final responder (based on diary)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 V
- •Patient has negative urine test at screening visit V1 for the following drugs of abuse:
- •Amphetamine
- •Metamphetamine
- •Tetrahydrocannabinol
Exclusion Criteria
- •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 V
- •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).
- •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).
Arms & Interventions
IGN-ES001
Polyclonal avian immunoglobulin IgY containing specific IgY against E. coli F18ab and S. typhimurium in partially delipidated avian egg yolk powder
Intervention: IGN-ES001
IGN-ES001
Polyclonal avian immunoglobulin IgY containing specific IgY against E. coli F18ab and S. typhimurium in partially delipidated avian egg yolk powder
Intervention: Parol 500 mg Tablets (acetaminophen)
Placebo
Polyclonal avian immunoglobulin IgY containing unspecific IgY in partially delipidated avian egg yolk powder
Intervention: Parol 500 mg Tablets (acetaminophen)
Outcomes
Primary Outcomes
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.
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 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.
Secondary Outcomes
- Change in Fibromyalgia Impact Questionnaire Revised version (FIQ-R) score from baseline (visit V2)(Six Weeks)
- Change in Fatigue Severity Scale (FSS) score from baseline (visit V2)(Six Weeks)
- Patient's Global Impression of Change (PCIG) Questionnaire(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)
- Responder* rate, alternative definition (based on diary)(Six Weeks)
- Consumption of rescue medication(Six Weeks)
- Time to first rescue medication (days)(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)