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

• Change in Visual Analogue Scale Evaluation (VASE) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
• Change in second Knee pain scale. [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
• Time to discontinuation of analgesic. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

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.

• Knee Pain
• Knee Chondroplasty

• Drug: Theramine
  Theramine 2 capsules 3 times per day
• Drug: Theramine- like placebo
  Theramine-like placebo capsules 2 three times daily

• Active Comparator: Theramine
  Theramine 2 capsules three times per day in addition to post surgical analgesic medication.
  Intervention: Drug: Theramine
• Placebo Comparator: Theramine-like Placebo
  Theramine-like placebo 2 capsules three times per day in addition to post surgical analgesic medication.
  Intervention: Drug: Theramine- like placebo

Inclusion Criteria:

• Diagnosed knee pain requiring chondroplasty knee arthroscopic surgery.
• 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.
• 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.
• 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.
• Must be willing to commit to all clinical visits during study-related procedures.
• Require use of narcotics for pain relief.

Exclusion Criteria:

• Patients with significant neurologic impairment, as diagnosed on screening physical examination.
• Patients not fluent in English.
• Patients currently involved in a Workman's Compensation case related to this procedure.
• Receipt of an oral intramuscular or soft-tissue injection of corticosteroid within one (1) month prior to screening.
• History of substance abuse.
• History of malignancy, other than basal or squamous cell of the skin within the last 5 years.
• Tibial plateau fracture within 6 months prior to surgery.