Clinical trial NCT03965819: A Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort
Official title: A Randomized, Double-blind, Placebo-controlled, Cross-over, Pilot Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Aches
Discomfort
Healthy
Adults
Body aches
Lead sponsor: LifeSeasons Inc.
Sponsor class: INDUSTRY
Collaborators: name: KGK Science Inc.
First posted: 2019-05-29
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled, cross-over
Primary purpose: OTHER

Brief summary: A randomized, double-blind, placebo-controlled, cross-over pilot study to investigate the efficacy of Pain Bloc-R in healthy participants with non-pathological aches and discomfort. The study will have 3 study periods. During each study period, eligible participants will consume either Pain Bloc-R, comparator product, or placebo for 7 days during each study period (1 product per study period), with a 1-week washout period in between each period. The primary objective is the comparison of change in unresolved aches and discomfort from pre-supplement to Day 7 between the Pain Bloc-R, comparator, and placebo, as assessed by the Brief Pain Inventory (BPI) questionnaire.


Eligibility criteria: Inclusion Criteria:

1. Males and females 18-65 years of age, inclusive
2. BMI of 18-32.5 kg/m2, inclusive
3. Individuals with occupational (construction workers, manual labourers, athletes) and non-occupational unresolved aches and discomfort for at least 2 weeks
4. Individuals on non-prescription, OTC medication for unresolved aches and discomfort and are willing to undergo a washout determined by the QI based on dose and frequency prior to enrollment
5. Female participants not of child bearing potential, defined as females who have had a hysterectomy or bilateral oophorectomy, bilateral tubal ligation, total endometrial ablation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) or, Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

   * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
   * Double-barrier method
   * Intrauterine devices
   * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
   * Vasectomy of partner at least 6 months prior to screening
6. Healthy as determined by laboratory results and medical history as assessed by the QI
7. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
8. Agrees to comply with study procedures
9. Has given voluntary, written, informed consent to participate in the study

Exclusion Criteria:

1. Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
2. Anticipated problems or allergy to any ingredients in the investigational products
3. Allergy to rescue medication
4. Have chronic disease conditions causing chronic pain
5. Uncontrolled high and low blood pressure
6. Uncontrolled blood sugar levels
7. Clinically significant abnormal laboratory results at screening
8. Prescribed medications used to help with aches and discomfort (Section 7.3.1)
9. OTC medications and supplements taken to help with aches and discomfort (Section 7.3.2)
10. Autoimmune disease or if immune-compromised (i.e. HIV-positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C-positive)
11. Cancer, except skin cancers completely excised with no chemotherapy or radiation with a follow-up that is negative. Volunteers with cancer in full remission for more than 5 years after diagnosis are acceptable after review by QI
12. History of mental illness that might impair the ability of participants to provide written informed consent
13. Current or history of bleeding disorders
14. Current or history of liver or kidney disease as assessed by QI on a case by case basis.
15. Current or pre-existing unstable thyroid condition. Treatment on a stable dose medication for over one year will be reviewed on a case-by-base basis by the QI
16. Surgical procedures which may impact the study outcomes within the past 3 months to be assessed by the QI
17. Medicinal marijuana
18. Recreational marijuana; dose and frequency to be assessed by QI
19. Alcohol intake \>2 standard drinks per day or \>10 standard drinks per week
20. Illicit drug use in the past 6 months as assessed by the QI
21. Participation in clinical trials within 30 days prior to screening visit
22. Blood donation during or within 30 days after conclusion of clinical trial
23. Any other active or unstable medical condition, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant.

Primary outcomes:
measure: Comparison of change in unresolved aches and discomfort from pre-supplementation to Day 7 between Pain Bloc-R, comparator and placebo as assessed by the Brief Pain Inventory (BPI) questionnaire
timeFrame: 7 days
Secondary outcomes:
measure: Comparison between Pain Bloc-R formula, comparator, and placebo in the change in musculoskeletal discomfort (MD) from pre-supplementation to Day 7 post-supplementation as assessed by modified Cornell musculoskeletal discomfort questionnaire
timeFrame: 7 days
measure: Comparison between Pain Bloc-R formula, comparator, and placebo in the change in general discomfort from pre-supplementation to Day 7 post-supplementation as assessed by the BPI questionnaire
timeFrame: 7 days
measure: Comparison between Pain Bloc-R formula, comparator, and placebo in the proportion of participants consuming rescue medicine when taking Pain Bloc-R, comparator, or placebo
timeFrame: 7 days
measure: Comparison between Pain Bloc-R formula, comparator, and placebo in Product perception and tolerability as assessed by the product perception questionnaire
timeFrame: 7 days
Other outcomes:
measure: The incidence of pre- and post-emergent adverse events (AEs) in the Pain Bloc-R formula, comparator, and placebo groups from pre-supplementation to Day 7
timeFrame: 7 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on systolic blood pressure from pre-supplementation to Day 7 post-supplementation
timeFrame: 7 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on diastolic blood pressure from pre-supplementation to Day 7 post-supplementation
timeFrame: 7 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on heart rate from pre-supplementation to Day 7 post-supplementation
timeFrame: 7 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on weight from pre-supplementation to Day 7 post-supplementation
timeFrame: 7 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on body mass index (BMI) from pre-supplementation to Day 7 post-supplementation
timeFrame: 7 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by alanine aminotransferase (ALT) levels in the blood
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by aspartate aminotransferase (AST) levels in the blood
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by bilirubin levels in the blood
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by creatinine levels in the blood
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by sodium levels in the blood
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by potassium levels in the blood
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on clinical chemistry from screening to end-of-study as assessed by chloride levels in the blood
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by hemoglobin
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by hematocrit
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by platelet count
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by red blood cell (RBC) count
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by red blood cell (RBC) indices
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by red cell distribution width (RDW)
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by white blood cell (WBC) count
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by neutrophils
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by lymphocytes
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by monocytes
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by eosinophils
timeFrame: Between 42-87 days
measure: The effect of supplementation with Pain Bloc-R formula, comparator, or placebo on hematology from screening to end-of-study as assessed by basophils
timeFrame: Between 42-87 days
Locations:
city: London
country: Canada
facility: KGK Science Inc.
state: Ontario
Study officials:
affiliation: Qualified Investigator
name: David Crowley, MD
role: PRINCIPAL_INVESTIGATOR
References: