MedTrace Logo

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

NCT01534286 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-05-05

No results posted yet for this study

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.

Conditions

  • Knee Pain
  • Knee Chondroplasty

Interventions

DRUG

Theramine

Theramine 2 capsules 3 times per day

DRUG

Theramine- like placebo

Theramine-like placebo capsules 2 three times daily

Sponsors & Collaborators

  • Targeted Medical Pharma

    lead INDUSTRY

Principal Investigators

  • Gregory V. Hickman, MD · Andrews-Paulos Research & Education Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01534286 on ClinicalTrials.gov