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

Targeted Medical Pharma

Status and phase: Terminated; Phase 4

Conditions: Knee Chondroplasty; Knee Pain

Treatments: Drug: Theramine- like placebo; Drug: Theramine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01534286

0201302

Details and patient eligibility

About

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.

Full description

No other decription

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8 participants in 2 patient groups, including a placebo group

Theramine

Active Comparator group

Description:

Theramine 2 capsules three times per day in addition to post surgical analgesic medication.

Treatment:

Drug: Theramine

Theramine-like Placebo

Placebo Comparator group

Description:

Theramine-like placebo 2 capsules three times per day in addition to post surgical analgesic medication.

Treatment:

Drug: Theramine- like placebo