HealthyNCT03965819
A Study to Investigate the Efficacy of Pain Bloc-R in Healthy Participants With Non-pathological Aches and Discomfort
A study testing Pain Bloc-R and Active Comparator - Acetaminophen in people with Healthy, run by LifeSeasons Inc. at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pain Bloc-R and Active Comparator - Acetaminophen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2019to 9 Aug 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females 18-65 years of age, inclusive
- BMI of 18-32.5 kg/m2, inclusive
- Individuals with occupational (construction workers, manual labourers, athletes) and non-occupational unresolved aches and discomfort for at least 2 weeks
- 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
- 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)
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- 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
- Healthy as determined by laboratory results and medical history as assessed by the QI
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
- Agrees to comply with study procedures
- Has given voluntary, written, informed consent to participate in the study
Who cannot join
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
- Anticipated problems or allergy to any ingredients in the investigational products
- Allergy to rescue medication
- Have chronic disease conditions causing chronic pain
- Uncontrolled high and low blood pressure
- Uncontrolled blood sugar levels
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- Clinically significant abnormal laboratory results at screening
- Prescribed medications used to help with aches and discomfort (Section 7.3.1)
- OTC medications and supplements taken to help with aches and discomfort (Section 7.3.2)
- Autoimmune disease or if immune-compromised (i.e. HIV-positive, use of anti-rejection medication, rheumatoid arthritis, Hepatitis B/C-positive)
- 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
- History of mental illness that might impair the ability of participants to provide written informed consent
- Current or history of bleeding disorders
- Current or history of liver or kidney disease as assessed by QI on a case by case basis.
- 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
- Surgical procedures which may impact the study outcomes within the past 3 months to be assessed by the QI
- Medicinal marijuana
- Recreational marijuana; dose and frequency to be assessed by QI
- Alcohol intake >2 standard drinks per day or >10 standard drinks per week
- Illicit drug use in the past 6 months as assessed by the QI
- Participation in clinical trials within 30 days prior to screening visit
- Blood donation during or within 30 days after conclusion of clinical trial
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Pain Bloc-R, Active Comparator - Acetaminophen, Placebo
- Keywords
- Aches, Discomfort, Healthy, Adults, Body aches
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Bloc-RDietary supplement
Herbal Supplement containing Vit D3, Vit B6, Vit B12, White Willow Bark, Angelica Root, Acetyl L-carnitine HCl, Caffeine, L-Theanine, Benfotiamine, and L-Tetrahydropalmatine
Active Comparator - AcetaminophenOther
DIN 02447479 Encapsulated for Blinding Purposes
PlaceboOther
No active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Randomized to consume Pain Bloc-R, Acetaminophen, then placebo | Experimental | Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Investigational Natural Health Product in Study Period 1, Comparator in Study Period 2, and Placebo in Study Period 3. Receives: Dietary Supplement: Pain Bloc-R; Other: Active Comparator - Acetaminophen; Other: Placebo |
| Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R | Experimental | Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Comparator in Study Period 1, Placebo in Study Period 2, and the Investigational Product in Study Period 3. Receives: Dietary Supplement: Pain Bloc-R; Other: Active Comparator - Acetaminophen; Other: Placebo |
| Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen | Experimental | Each study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Placebo in Study Period 1, Investigational Product in Study Period 2, and Comparator in Study Period 3. Receives: Dietary Supplement: Pain Bloc-R; Other: Active Comparator - Acetaminophen; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
The Brief Pain Inventory (BPI) questionnaire developed by MD Anderson Cancer Centre is a discomfort assessment tool used to score an individual's level of discomfort severity and discomfort interference.
Part A of the questionnaire evaluates pain severity, asking the participants to rate their "worst", "least", "average" and "right now" (current) levels of pain on a scale of 0 (no pain) to 10 (as bad as you can imagine).
Part B evaluates the pain interference levels, asking the participants to rate the impact of their pain on their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. Together, part A and part B aim to serve as a concise quantification tool for the pain levels and the participant's resulting quality of life. The questionnaire will be administered at each visit to monitor changes in participant's pain over the course of each phase.
Measured: 7 days
Secondary outcomes (4)
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
The modified Cornell Musculoskeletal Discomfort Questionnaire (mCMDQ) tool is used to assess physical discomfort. The questionnaire includes a list of body parts with an image for visualization. The questionnaire assesses the discomfort frequency score, from "never" (Rating Score = 0), "1-2 times/week" (RS 1.5), "3-4 times/week" (RS 3.5), "every day" (RS 5) and "several times a day" (RS 10). The questionnaire assesses discomfort severity score, as "slightly uncomfortable" (RS 1), "moderately uncomfortable" (RS = 2) or "very uncomfortable" (RS 3). Finally, the questionnaire determines the discomfort interference score, as "not at all" (RS 1), "slightly interfered" (RS 2), or "interfered a lot" (RS 3). The total discomfort score is calculated by multiplying the individual frequency, severity and interference scores for each body part, and then summed to yield a total discomfort score.
Measured: 7 days
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
The Brief Pain Inventory (BPI) questionnaire developed by MD Anderson Cancer Centre is a discomfort assessment tool used to score an individual's level of discomfort severity and discomfort interference.
Part A of the questionnaire evaluates pain severity, asking the participants to rate their "worst", "least", "average" and "right now" (current) levels of pain on a scale of 0 (no pain) to 10 (as bad as you can imagine).
Part B evaluates the pain interference levels, asking the participants to rate the impact of their pain on their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. Together, part A and part B aim to serve as a concise quantification tool for the pain levels and the participant's resulting quality of life. The questionnaire will be administered at each visit to monitor changes in participant's pain over the course of each phase.
Measured: 7 days
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
Measured: 7 days
Comparison between Pain Bloc-R formula, comparator, and placebo in Product perception and tolerability as assessed by the product perception questionnaire
A questionnaire containing 7 questions regarding the participants satisfaction, tolerability, and feelings toward the study product. The product perception questionnaire will be scored from 5,4,3,2,1 for strongly agree, agree, no opinion, disagree, strongly disagree respectively on each question. Min and max scores for each question are 1 and 5. The total score of the 7 questions is the sum scores of each question with the min and max of 1 and 35. The higher score indicates better product perception for each question and total score.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start30 May 2019
- Primary completion9 Aug 2019
- Study completion9 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, double-blind, placebo-controlled, cross-over
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeSeasons Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, Qualified Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965819
- Sponsor's protocol ID
- 18PPHL
- Status last verified
- Aug 2019
- First submitted
- 24 May 2019
- Last updated
- 13 Aug 2019
- 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 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03965819
- Acronym / sponsor ID
- 18PPHL
- Conditions
- Healthy
- Keywords
- Aches, Discomfort, Healthy, Adults, Body aches
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- LifeSeasons Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- 30 May 2019 (actual)
- Primary completion
- 9 Aug 2019 (actual)
- Study completion
- 9 Aug 2019 (actual)
- First posted
- 29 May 2019 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, double-blind, placebo-controlled, cross-over
| Arm | Type | Receives |
|---|---|---|
| Randomized to consume Pain Bloc-R, Acetaminophen, then placebo | Experimental | Dietary Supplement: Pain Bloc-R, Other: Active Comparator - Acetaminophen, Other: PlaceboEach study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Investigational Natural Health Product in Study Period 1, Comparator in Study Period 2, and Placebo in Study Period 3. |
| Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R | Experimental | Dietary Supplement: Pain Bloc-R, Other: Active Comparator - Acetaminophen, Other: PlaceboEach study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Comparator in Study Period 1, Placebo in Study Period 2, and the Investigational Product in Study Period 3. |
| Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen | Experimental | Dietary Supplement: Pain Bloc-R, Other: Active Comparator - Acetaminophen, Other: PlaceboEach study product will be consumed as 2 capsules daily for 7 days. Randomized to consume Placebo in Study Period 1, Investigational Product in Study Period 2, and Comparator in Study Period 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Males and females 18-65 years of age, inclusive
- BMI of 18-32.5 kg/m2, inclusive
- Individuals with occupational (construction workers, manual labourers, athletes) and non-occupational unresolved aches and discomfort for at least 2 weeks
- 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
- 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:
Key exclusion criteria (23 listed)
- Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
- Anticipated problems or allergy to any ingredients in the investigational products
- Allergy to rescue medication
- Have chronic disease conditions causing chronic pain
- Uncontrolled high and low blood pressure
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 |
|---|---|---|
| Pain Bloc-RHerbal Supplement containing Vit D3, Vit B6, Vit B12, White Willow Bark, Angelica Root, Acetyl L-carnitine HCl, Caffeine, L-Theanine, Benfotiamine, and L-Tetrahydropalmatine | Dietary supplement | Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R, Randomized to consume Pain Bloc-R, Acetaminophen, then placebo, Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen |
| Active Comparator - AcetaminophenDIN 02447479 Encapsulated for Blinding Purposes | Other | Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R, Randomized to consume Pain Bloc-R, Acetaminophen, then placebo, Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen |
| PlaceboNo active ingredients | Other | Randomized to consume Acetaminophen, Placebo, then Pain Bloc-R, Randomized to consume Pain Bloc-R, Acetaminophen, then placebo, Randomized to consume Placebo, Pain Bloc-R, then Acetaminophen |
Primary outcome
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
Time frame: 7 days
The Brief Pain Inventory (BPI) questionnaire developed by MD Anderson Cancer Centre is a discomfort assessment tool used to score an individual's level of discomfort severity and discomfort interference. Part A of the questionnaire evaluates pain severity, asking the participants to rate their "worst", "least", "average" and "right now" (current) levels of pain on a scale of 0 (no pain) to 10 (as bad as you can imagine). Part B evaluates the pain interference levels, asking the participants to rate the impact of their pain on their general activity, mood, walking ability, normal work, relations with other people, sleep and enjoyment of life. Together, part A and part B aim to serve as a concise quantification tool for the pain levels and the participant's resulting quality of life. The questionnaire will be administered at each visit to monitor changes in participant's pain over the course of each phase.
4 secondary outcomes
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
Comparison between Pain Bloc-R formula, comparator, and placebo in Product perception and tolerability as assessed by the product perception questionnaire
Time frame: 7 days
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 13 Aug 2019.
- 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.
David Crowley, MD principal investigator
Qualified Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Bloc-R and Active Comparator - Acetaminophen in people with Healthy, run by LifeSeasons Inc. at 1 site in Canada.
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 14 inclusion and 23 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. 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?
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 (time frame: 7 days). 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 13 Aug 2019.