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

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.

Study Overview

• Status: Terminated
• Conditions: Knee Pain; Knee Chondroplasty
• Intervention / Treatment: Drug: Theramine; Drug: Theramine- like placebo

Detailed Description

No other decription

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • Andrews-Paulos Research & Education Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose reduction of analgesic.	The primary efficacy outcome will be the overall dose reduction of analgesic in the Theramine active group versus the Theramine placebo group.	28 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Visual Analogue Scale Evaluation (VASE)	28 days
Change in second Knee pain scale.	28 Days
Time to discontinuation of analgesic.	28 days

Collaborators and Investigators

• Sponsor: Targeted Medical Pharma
• Investigators: Principal Investigator: Gregory V. Hickman, MD, Andrews-Paulos Research & Education Institute

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: February 13, 2012
• First Submitted That Met QC Criteria: February 13, 2012
• First Posted (Estimate): February 16, 2012

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 4, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Knee surgery; Theramine; Prescription Medical Food
• Other Study ID Numbers: 0201302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Too small data set to draw any conclusions