Clinical trial NCT02193711: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Lead sponsor: Delivra, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-18
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in mean daily pain diary score from baseline
timeFrame: three weeks
Secondary outcomes:
measure: WOMAC
timeFrame: Six weeks
measure: BPI-SF
timeFrame: six weeks
measure: PGIC
timeFrame: six weeks
measure: PGSS
timeFrame: six weeks
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: CDHA - Pain Management Unit
state: Nova Scotia
city: Toronto
country: Canada
facility: Canadian College of Naturopathic Medicine
state: Ontario
Study officials:
References: