A Randomized Double-Blind Placebo Controlled Trial to Determine the Status of Post Knee Chondroplasty Patients Administered Theramine Versus Placebo in Addition to Post Surgery Analgesics
Study Details
Study Description
Brief Summary
The purpose of this study will be to show the patient response to analgesics taken post surgery when taken in combination with Theramine as opposed to Theramine-like placebo. The data collected will be used to show that patients have a shorter and lower post operative pain measurement and the time to discontinuation of analgesics is less in the active comparator group.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
No other decription
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Theramine Theramine 2 capsules three times per day in addition to post surgical analgesic medication. |
Drug: Theramine
Theramine 2 capsules 3 times per day
|
| Placebo Comparator: Theramine-like Placebo Theramine-like placebo 2 capsules three times per day in addition to post surgical analgesic medication. |
Drug: Theramine- like placebo
Theramine-like placebo capsules 2 three times daily
|
Outcome Measures
Primary Outcome Measures
- Dose reduction of analgesic. [28 days]
The primary efficacy outcome will be the overall dose reduction of analgesic in the Theramine active group versus the Theramine placebo group.
Secondary Outcome Measures
- Change in Visual Analogue Scale Evaluation (VASE) [28 days]
- Change in second Knee pain scale. [28 Days]
- Time to discontinuation of analgesic. [28 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed knee pain requiring chondroplasty knee arthroscopic surgery.
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Men and non-pregnant, non-lactating women over the age of 18 and under the age of 75, able to read, understand and sign English-language informed consent.
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If using psychoactive medication which might have analgesic effects, (i.e. anti-depressants or anti-consultants), treatment must be stable for at least three (3) months prior to study.
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For men and women of child-bearing potential, must be willing to use adequate contraception and not be pregnant or impregnate their partner during the entire time of study.
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Must be willing to commit to all clinical visits during study-related procedures.
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Require use of narcotics for pain relief.
Exclusion Criteria:
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Patients with significant neurologic impairment, as diagnosed on screening physical examination.
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Patients not fluent in English.
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Patients currently involved in a Workman's Compensation case related to this procedure.
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Receipt of an oral intramuscular or soft-tissue injection of corticosteroid within one (1) month prior to screening.
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History of substance abuse.
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History of malignancy, other than basal or squamous cell of the skin within the last 5 years.
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Tibial plateau fracture within 6 months prior to surgery.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Andrews-Paulos Research & Education Institute | Gulf Breeze | Florida | United States | 32561 |
Sponsors and Collaborators
- Targeted Medical Pharma
Investigators
- Principal Investigator: Gregory V. Hickman, MD, Andrews-Paulos Research & Education Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 0201302