OsteoarthritisPhase 3NCT02193711
Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
A Phase 3 study testing Topical Arthritis Cream in people with Osteoarthritis, run by Delivra, Inc. at 2 sites in Canada.
Trial summary
The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy of a topical cream compared to a placebo cream. The study population will be those with mild to moderate osteoarthritis of the knee. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Topical Arthritis Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 3
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3:
- age >50 years
- stiffness less than 30 min
- crepitus,
- bony tenderness,
- bony enlargement,
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- no palpable warmth
- Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
- All concurrent medications taken for any reason stable for 14 days
- Ability to follow protocol with reference to cognitive and situational factors (eg. stable housing, ability to attend visits)
- Ability to read and write English
- Willing and able to give informed consent
Who cannot join
- Currently taking opioids, NSAIDs, warfarin, other anticoagulants, other topical agents for treatment of pain or inflammation
- Allergy to tea tree oil, latex, avocado, soy
- Active conditions such as exzema or psoriasis
- Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg. cancer, immunosuppressed)
- Individuals with a history or current disease which may affect the outcome of the trial (ie. Inflammatory, infections joint disease).
- Allergy to plants of the Asteraceae/Compositae/Daisy family.
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- Pregnant and breastfeeding women.
- Allergy or other contraindication for acetaminophen use.
- Exercise or transcutaneous electrical nerve stimulation should be excluded prior to and during the trial.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
CDHA - Pain Management Unit
Halifax, Nova Scotia, B3H 2Y9
Canadian College of Naturopathic Medicine
Toronto, Ontario, M2K 1E2
About this study
Official title: Randomized, Double Blind, Placebo Controlled Trial With Open Label Extension Of Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy of a topical cream compared to a placebo cream. The study population will be those with mild to moderate osteoarthritis of the knee.
The trial will also provide information about potential side effects and verify the safety of this composition. Blood levels will be done to assess inflammation and to determine whether any systemic absorption has occurred.
Read more
Hypothesis/Purpose
- Pain scores after active treatment will be significantly reduced in comparison to placebo.
- There will be an improvement in stiffness and physical function as measured by the WOMAC using the active cream as compared to placebo.
- There will be a decrease in the level of inflammation assessed at baseline, end of week 3 and end of week 6.
- The blood concentration of the active ingredient in the topical cream will not exceed the maximum daily dose that will be consumed by participants.
- Conditions
- Osteoarthritis
- Being tested
- Topical Arthritis Cream
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Arthritis CreamOther
Also called LivRelief Pharmax Rebuild
| Study group | Role | What they receive |
|---|---|---|
| Topical Arthritis Cream | Experimental | 1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day. Receives: Other: Topical Arthritis Cream |
| Placebo | Placebo comparator | 1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day. Receives: Other: Topical Arthritis Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean daily pain diary score from baseline
The primary outcome measure will consist of change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final 3 days of the third treatment week. Therefore, the primary analysis is a between group comparison (placebo versus test product) over 3 weeks.
Measured: three weeks
Secondary outcomes (4)
WOMAC
The Western Ontario and McMaster Universities Arthritis Index is a well validated and widely used measure to assess pain, stiffness and physical function in individuals with OA of the knee or hip. It consists of 24 questions divided into 3 scales (pain, stiffness and physical function). This scale has been found to be sensitive to interventions used for osteoarthritis and is noted by IMMPACT as an example of an appropriate disease specific measure of physical function.
Measured: Six weeks
BPI-SF
The BPI pain scale has been widely used and found to provide a reliable and valid measure of pain and pain's interference with physical functioning in seven areas including: general activity, mood, walking ability, work, relations with other people, sleep and enjoyment of life. The instrument consists of a series of 11-point numeric rating scales asking the participant to rate the pain and indicate how much the pain has interfered with seven areas (0 indicating "does not interfere", 10 indicating "completely interferes").
Measured: six weeks
PGIC
The Patient Global Impression of Change Scale (PGIC). This measure is a single-item rating by participants of their improvement with treatment on a 7-point scale that ranges from "very much improved' to "very much worse" with "no-change, as the mid-point.
Measured: six weeks
PGSS
The Patient Global Satisfaction Scale (PGSS) is a 10-point scale with verbal descriptors ranging from "very satisfied" to "not at all satisfied.
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delivra, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193711
- Sponsor's protocol ID
- Delivra-001
- Status last verified
- Jan 2018
- First submitted
- 16 Jul 2014
- Last updated
- 1 Feb 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Trial With Open Label Extension Of Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
- ClinicalTrials.gov ID
- NCT02193711
- Acronym / sponsor ID
- Delivra-001
- Conditions
- Osteoarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Delivra, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Jul 2014 (estimated)
- 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.
The current clinical trial is designed to test the analgesic and anti-inflammatory efficacy of a topical cream compared to a placebo cream. The study population will be those with mild to moderate osteoarthritis of the knee.
The trial will also provide information about potential side effects and verify the safety of this composition. Blood levels will be done to assess inflammation and to determine whether any systemic absorption has occurred.
Hypothesis/Purpose
- Pain scores after active treatment will be significantly reduced in comparison to placebo.
- There will be an improvement in stiffness and physical function as measured by the WOMAC using the active cream as compared to placebo.
- There will be a decrease in the level of inflammation assessed at baseline, end of week 3 and end of week 6.
- The blood concentration of the active ingredient in the topical cream will not exceed the maximum daily dose that will be consumed by participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Arthritis Cream | Experimental | Other: Topical Arthritis Cream1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day. |
| Placebo | Placebo comparator | Other: Topical Arthritis Cream1-1.5 ml applied to the skin over the knee in the morning and at bedtime over the entire study period, for a total of 2-3 ml/day. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Osteoarthritis of the knee according to American College of Rheumatology criteria: Knee pain with 3:
- Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity (NRS-PI).
- All concurrent medications taken for any reason stable for 14 days
- Ability to follow protocol with reference to cognitive and situational factors (eg. stable housing, ability to attend visits)
- Ability to read and write English
Key exclusion criteria (9 listed)
- Currently taking opioids, NSAIDs, warfarin, other anticoagulants, other topical agents for treatment of pain or inflammation
- Allergy to tea tree oil, latex, avocado, soy
- Active conditions such as exzema or psoriasis
- Presence of significant medical disorder that would compromise the participant's safety to take part in the trial (eg. cancer, immunosuppressed)
- Individuals with a history or current disease which may affect the outcome of the trial (ie. Inflammatory, infections joint disease).
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 |
|---|---|---|
| Topical Arthritis CreamAlso: LivRelief Pharmax Rebuild | Other | Placebo, Topical Arthritis Cream |
Primary outcome
Change in mean daily pain diary score from baseline
Time frame: three weeks
The primary outcome measure will consist of change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final 3 days of the third treatment week. Therefore, the primary analysis is a between group comparison (placebo versus test product) over 3 weeks.
4 secondary outcomes
WOMAC
Time frame: Six weeks
BPI-SF
Time frame: six weeks
PGIC
Time frame: six weeks
PGSS
Time frame: six weeks
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 1 Feb 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Topical Arthritis Cream in people with Osteoarthritis, run by Delivra, Inc. at 2 sites 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 12 inclusion and 9 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 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
Change in mean daily pain diary score from baseline (time frame: three weeks). 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 1 Feb 2018.