Status:
COMPLETED
Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
Lead Sponsor:
Delivra, Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-100 years
Phase:
PHASE3
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 ost...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT02193711
Start Date
January 1 2015
End Date
December 1 2017
Last Update
February 1 2018
Active Locations (2)
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1
CDHA - Pain Management Unit
Halifax, Nova Scotia, Canada, B3H 2Y9
2
Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada, M2K 1E2