Delivra Joint Health Cream In The Treatment Of Pain Caused By Osteoarthritis Of The Knee
| Status: | Recruiting |
|---|---|
| Conditions: | Arthritis, Osteoarthritis (OA) |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/11/2015 |
| Start Date: | January 2015 |
| Contact: | Joseph Gabriele, PhD |
| Email: | jgabriele@delivrainc.com |
| Phone: | 905-928-4567 |
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.
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.
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.
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.
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