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 | Terminated Phase 4

• 1 other identifier: 0201302
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Pain; Knee Chondroplasty

Keywords

Prescription Medical Food; Theramine; Knee surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Visual Analogue Scale Evaluation (VASE)

  28 days

• Change in second Knee pain scale.

  28 Days

• Time to discontinuation of analgesic.

  28 days

Study Arms (2)

Theramine

ACTIVE COMPARATOR

Theramine 2 capsules three times per day in addition to post surgical analgesic medication.

Drug: Theramine

Theramine-like Placebo

PLACEBO COMPARATOR

Theramine-like placebo 2 capsules three times per day in addition to post surgical analgesic medication.

Drug: Theramine- like placebo

Interventions

Theramine DRUG

Theramine 2 capsules 3 times per day

Theramine

Theramine- like placebo DRUG

Theramine-like placebo capsules 2 three times daily

Theramine-like Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Targeted Medical Pharma: lead

Study Sites (1)

Andrews-Paulos Research & Education Institute

Gulf Breeze, Florida, 32561, United States

Location

Related Links

• Related Info

Study Officials

• Gregory V. Hickman, MD

  Andrews-Paulos Research & Education Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 16, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 5, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)