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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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No other decription

Conditions

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Knee Pain Knee Chondroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Theramine

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

Group Type ACTIVE_COMPARATOR

Theramine

Intervention Type DRUG

Theramine 2 capsules 3 times per day

Theramine-like Placebo

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

Group Type PLACEBO_COMPARATOR

Theramine- like placebo

Intervention Type DRUG

Theramine-like placebo capsules 2 three times daily

Interventions

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Theramine

Theramine 2 capsules 3 times per day

Intervention Type DRUG

Theramine- like placebo

Theramine-like placebo capsules 2 three times daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No