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

Knee Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01534286
• Other study ID #: 0201302
• Status: Terminated
• Phase: Phase 4
• First received: February 13, 2012
• Last updated: May 4, 2016
• Start date: August 2012
• Est. completion date: December 2013

Study information

• Verified date: May 2016
• Source: Targeted Medical Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

No other decription

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Knee Chondroplasty
• Knee Pain

Intervention

Drug:
• Theramine
Theramine 2 capsules 3 times per day
• Theramine- like placebo
Theramine-like placebo capsules 2 three times daily

Locations

Country	Name	City	State
United States	Andrews-Paulos Research & Education Institute	Gulf Breeze	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Targeted Medical Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Visual Analogue Scale Evaluation (VASE)		28 days	No
Secondary	Change in second Knee pain scale.		28 Days	No
Secondary	Time to discontinuation of analgesic.		28 days	No

External Links

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