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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Targeted Medical Pharma
ClinicalTrials.gov Identifier:
NCT01534286
First received: February 13, 2012
Last updated: July 24, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Knee Pain
Knee Chondroplasty
Drug: Theramine
Drug: Theramine- like placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Targeted Medical Pharma:

Primary Outcome Measures:
  • Dose reduction of analgesic. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    The primary efficacy outcome will be the overall dose reduction of analgesic in the Theramine active group versus the Theramine placebo group.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: August 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534286

Locations
United States, Florida
Andrews-Paulos Research & Education Institute
Gulf Breeze, Florida, United States, 32561
Sponsors and Collaborators
Targeted Medical Pharma
Investigators
Principal Investigator: Gregory V. Hickman, MD Andrews-Paulos Research & Education Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Targeted Medical Pharma
ClinicalTrials.gov Identifier: NCT01534286     History of Changes
Other Study ID Numbers: 0201302
Study First Received: February 13, 2012
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Targeted Medical Pharma:
Prescription Medical Food
Theramine
Knee surgery

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014