Chronic Widespread Pain, Fibromyalgia
Conditions
Keywords
Pain, Symptom Severity, Immunoglobulin IgY, Fibromyalgia, Widespread Pain Index, Eggyolk, FIQ-R, SF-36v2TM, MOS-SS, FSS, PGIC, Quality of life
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.
Interventions
DRUGIGN-ES001
Only active product will be compared with placebo as described in Arms and Interventions.
DRUGParol 500 mg Tablets (acetaminophen)
Analgesic Rescue Medication
Sponsors
Scope International AG
Klinar CRO
CenTrial GmbH
Pharmasolutions4U
idv Data Analysis and Study Planning
IgNova GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain, final percent changes from baseline (based on diary), univariate analysis | 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 | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Patient's Global Impression of Change (PCIG) Questionnaire | 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. |
| 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 | — |
Countries
Turkey (Türkiye)
Outcome results
None listed