Back to resultsDelivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Topical Arthritis Cream
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
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,
- 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
Exclusion Criteria:
- 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.
- 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.
Sites / Locations
- CDHA - Pain Management Unit
- Canadian College of Naturopathic Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Topical Arthritis Cream
Placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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").
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.
PGSS
The Patient Global Satisfaction Scale (PGSS) is a 10-point scale with verbal descriptors ranging from "very satisfied" to "not at all satisfied.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02193711
Brief Title
Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Delivra, Inc.
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical Arthritis Cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Topical Arthritis Cream
Other Intervention Name(s)
LivRelief Pharmax Rebuild
Primary Outcome Measure Information:
Title
Change in mean daily pain diary score from baseline
Description
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.
Time Frame
three weeks
Secondary Outcome Measure Information:
Title
WOMAC
Description
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.
Time Frame
Six weeks
Title
BPI-SF
Description
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").
Time Frame
six weeks
Title
PGIC
Description
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.
Time Frame
six weeks
Title
PGSS
Description
The Patient Global Satisfaction Scale (PGSS) is a 10-point scale with verbal descriptors ranging from "very satisfied" to "not at all satisfied.
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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,
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
Exclusion Criteria:
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.
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.
Facility Information:
Facility Name
CDHA - Pain Management Unit
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Canadian College of Naturopathic Medicine
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M2K 1E2
Country
Canada
12. IPD Sharing Statement
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Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
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