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
Trial Snapshot
- Phase
- Phase 4
- Status
- Terminated
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Dose reduction of analgesic.
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Theramine
Theramine 2 capsules three times per day in addition to post surgical analgesic medication.
Intervention: Theramine (Drug)
Theramine-like Placebo
Theramine-like placebo 2 capsules three times per day in addition to post surgical analgesic medication.
Intervention: Theramine- like placebo (Drug)
Outcomes
Primary Outcomes
Dose reduction of analgesic.
Time Frame: 28 days
The primary efficacy outcome will be the overall dose reduction of analgesic in the Theramine active group versus the Theramine placebo group.
Secondary Outcomes
- Change in second Knee pain scale.(28 Days)
- Change in Visual Analogue Scale Evaluation (VASE)(28 days)
- Time to discontinuation of analgesic.(28 days)