Osteoarthritis, KneeEarly Phase 1NCT03641248
Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract
A Early Phase 1 study testing Enteric coated Devil's Claw and Non-enteric coated Devil's Claw in people with Osteoarthritis, Knee, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
Study will define the bioavailability and short term pharmacokinetics of the principal secondary metabolites of a aqueous-ethanolic extract of H. procumbens in non-enteric and enteric capsules. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Enteric coated Devil's Claw and Non-enteric coated Devil's Claw
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to 31 Aug 2021
- Phase
- Early Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with knee osteoarthritis (OA) ;
- body mass index (BMI) of less than 40;
- willing to use only the study product, and Tramadol or Tylenol as a rescue pain medication over the course of their participation in the study;
- willing and able to monitor blood glucose levels if diabetic;
- willing to abstain from caffeine-containing drinks and food before coming into a study visit;
- able to read and understand English and have the cognitive capacity to give consent;
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- willing to abstain from use of the following during participation in the study: prescription and over-the-counter non-steroidal anti-inflammatory medications, (e.g., aspirin, ibuprofen, Advil, Motrin, Nuprin, Naproxen, etc.); any dietary supplements (St. John's Wort, etc.); and, grapefruit and/or products containing it.
- Exclusion Criteria:- cardiovascular disease, previous myocardial infarction, stent, coronary artery bypass graft (CABG), arrhythmia, high or low blood pressure;
- recurrent stomach upset, or gastric or duodenal ulcers;
- gallstones or gall bladder disease (cholelithiasis);
- liver or kidney disease;
- alcohol use of more than two drinks per day on a regular basis;
- Coumadin or anti-platelet drug use;
- at risk for respiratory depression, history of seizures, or taking drugs that reduce the seizure threshold or may increase the risk for development of serotonin syndrome;
- pregnant or breast feeding, or intention to become pregnant during the study;
- pronounced allergies, or known allergy to study product or corn starch (placebo);
- have had an injection to treat OA within the past three months;
- currently taking NSAIDs, unless they are willing to stop for a 1-week wash-out period;
- currently on a selective serotonin reuptake inhibitor (SSRI) but are poorly stabilized, or have evidence of suicidal ideation and/or suicide attempts in the past year; and,
- reported use during the 7 days prior to study drug administration of: prescription and over-the-counter medications (e.g., NSAIDs), and any dietary supplements; grapefruit and/or its products; and, St. John's Wort.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univ of Missouri Health Care Center
Columbia, Missouri, 65211
About this study
Official title: Study to Establish the Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract in Humans
Study will define the bioavailability and short term pharmacokinetics of the principal secondary metabolites of a aqueous-ethanolic extract of H. procumbens in non-enteric and enteric capsules.
Read the detailed description
The study(n = 12) will use a one-dose design to measure bioavailability and pharmacokinetic properties of an aqueous extract of H. procumbens containing 100mg harpagoside. Plasma levels of harpagoside, harpagide, verbascoside, and 8-p-coumarylharpagide will be measured for 24 hours with blood collections taken at timed intervals.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Enteric coated Devil's Claw, Non-enteric coated Devil's Claw
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteric coated Devil's ClawDrug
Also called Harpagophytum procumbens
Enteric coated capsules containing Devil's Claw extract with 100mg harpagoside
Non-enteric coated Devil's ClawDrug
Also called Harpagophytum procumbens
Non-enteric coated capsules containing Devil's Claw extract with 100mg harpagoside
| Study group | Role | What they receive |
|---|---|---|
| Enteric coated Devil's Claw | Experimental | H. procumbens 100 mg in enteric coated capsules Receives: Drug: Enteric coated Devil's Claw |
| Non-enteric coated Devil's Claw | Active comparator | H. procumbens 100 mg in non-enteric coated capsules Receives: Drug: Non-enteric coated Devil's Claw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal concentration level of Devil's Claw metabolites, Cmax (ng/ml)
Blood will be drawn at predefined intervals following administration of one dose of study drug
Measured: 0.5 hour, 1 hour, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 12 hours
Time to reach Cmax (h)
Blood will be drawn at predefined intervals following administration of one dose of study drug
Measured: 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
Determination of terminal half-life of Devil's Claw, t 1/2 (h)
Blood will be drawn at predefined intervals following administration of one dose of study drug
Measured: 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
Secondary outcomes (4)
Change in plasma levels of harpagoside
Blood will be drawn for Devil's Claws metabolites at Visit 2
Measured: 24 hours after dose of Devil's Claw
Change in plasma levels of harpagide
Blood will be drawn for Devil's Claws metabolites at Visit 2
Measured: 24 hours after dose of Devil's Claw
Change in plasma levels of verbascoside
Blood will be drawn for Devil's Claws metabolites at Visit 2
Measured: 24 hours after dose of Devil's Claw
Change in levels of 8-p-coumarylharpagide
Blood will be drawn for Devil's Claws metabolites at Visit 2
Measured: 24 hours after dose of Devil's Claw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start1 May 2021 (estimated)
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Why it stopped: Recruitment was not possible due to COVID19.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pharmacokinetic
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Folk, University of Missouri-Columbia
- Investigators
- William Folk, PhD, Principal investigator, Univ of Missouri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03641248
- Sponsor's protocol ID
- 2010425
- Other IDs
- US NIH Grant 7R21AT009086
- Status last verified
- May 2022
- First submitted
- 16 Aug 2018
- Last updated
- 26 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Establish the Bioavailability and Pharmacokinetic Measures of H. Procumbens Extract in Humans
- ClinicalTrials.gov ID
- NCT03641248
- Acronym / sponsor ID
- 2010425
- Conditions
- Osteoarthritis, Knee
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Recruitment was not possible due to COVID19.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 21 Aug 2018 (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.
Study will define the bioavailability and short term pharmacokinetics of the principal secondary metabolites of a aqueous-ethanolic extract of H. procumbens in non-enteric and enteric capsules.
Detailed description
The study(n = 12) will use a one-dose design to measure bioavailability and pharmacokinetic properties of an aqueous extract of H. procumbens containing 100mg harpagoside. Plasma levels of harpagoside, harpagide, verbascoside, and 8-p-coumarylharpagide will be measured for 24 hours with blood collections taken at timed intervals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Pharmacokinetic
| Arm | Type | Receives |
|---|---|---|
| Enteric coated Devil's Claw | Experimental | Drug: Enteric coated Devil's ClawH. procumbens 100 mg in enteric coated capsules |
| Non-enteric coated Devil's Claw | Active comparator | Drug: Non-enteric coated Devil's ClawH. procumbens 100 mg in non-enteric coated capsules |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- diagnosed with knee osteoarthritis (OA) ;
- body mass index (BMI) of less than 40;
- willing to use only the study product, and Tramadol or Tylenol as a rescue pain medication over the course of their participation in the study;
- willing and able to monitor blood glucose levels if diabetic;
- willing to abstain from caffeine-containing drinks and food before coming into a study visit;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Enteric coated Devil's ClawAlso: Harpagophytum procumbensEnteric coated capsules containing Devil's Claw extract with 100mg harpagoside | Drug | Enteric coated Devil's Claw |
| Non-enteric coated Devil's ClawAlso: Harpagophytum procumbensNon-enteric coated capsules containing Devil's Claw extract with 100mg harpagoside | Drug | Non-enteric coated Devil's Claw |
Primary outcome
Maximal concentration level of Devil's Claw metabolites, Cmax (ng/ml)
Time frame: 0.5 hour, 1 hour, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 12 hours
Blood will be drawn at predefined intervals following administration of one dose of study drug
Time to reach Cmax (h)
Time frame: 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
Blood will be drawn at predefined intervals following administration of one dose of study drug
Determination of terminal half-life of Devil's Claw, t 1/2 (h)
Time frame: 0 hour, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours
Blood will be drawn at predefined intervals following administration of one dose of study drug
4 secondary outcomes
Change in plasma levels of harpagoside
Time frame: 24 hours after dose of Devil's Claw
Change in plasma levels of harpagide
Time frame: 24 hours after dose of Devil's Claw
Change in plasma levels of verbascoside
Time frame: 24 hours after dose of Devil's Claw
Change in levels of 8-p-coumarylharpagide
Time frame: 24 hours after dose of Devil's Claw
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- 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.
William Folk, PhD principal investigator
Univ of Missouri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Enteric coated Devil's Claw and Non-enteric coated Devil's Claw in people with Osteoarthritis, Knee, run by University of Missouri-Columbia at 1 site in United States.
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 20 inclusion and 0 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: withdrawn, as of the sponsor's last update on 26 May 2022. 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 United States. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Maximal concentration level of Devil's Claw metabolites, Cmax (ng/ml) (time frame: 0.5 hour, 1 hour, 2 hours, 2.5 hours, 3 hours, 4 hours, 5 hours, 6 hours, 7 hours, 8 hours, 9 hours, 10 hours, 12 hours). 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 26 May 2022.