Clinical trial NCT01534286: 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
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Knee Pain
Knee Chondroplasty
Keywords: Prescription Medical Food
Theramine
Knee surgery
Lead sponsor: Targeted Medical Pharma
Sponsor class: INDUSTRY
First posted: 2012-02-16
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: No other decription

Eligibility 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.

Primary outcomes:
measure: Dose reduction of analgesic.
timeFrame: 28 days
Secondary outcomes:
measure: Change in Visual Analogue Scale Evaluation (VASE)
timeFrame: 28 days
measure: Change in second Knee pain scale.
timeFrame: 28 Days
measure: Time to discontinuation of analgesic.
timeFrame: 28 days
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews-Paulos Research & Education Institute
state: Florida
Study officials:
affiliation: Andrews-Paulos Research & Education Institute
name: Gregory V. Hickman, MD
role: PRINCIPAL_INVESTIGATOR
References: