Knee PainPhase 4NCT01534286
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
A Phase 4 study testing Theramine in people with Knee Pain and Knee Chondroplasty, run by Targeted Medical Pharma at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Pain, Knee Chondroplasty
- What is being tested?
- Theramine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Andrews-Paulos Research & Education Institute
Gulf Breeze, Florida, 32561
About this study
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.
Read the detailed description
No other decription
- Conditions
- Knee Pain, Knee Chondroplasty
- Being tested
- Theramine, Theramine- like placebo
- Keywords
- Prescription Medical Food, Theramine, Knee surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheramineDrug
Theramine 2 capsules 3 times per day
Theramine- like placeboDrug
Theramine-like placebo capsules 2 three times daily
| Study group | Role | What they receive |
|---|---|---|
| Theramine | Active comparator | Theramine 2 capsules three times per day in addition to post surgical analgesic medication. Receives: Drug: Theramine |
| Theramine-like Placebo | Placebo comparator | Theramine-like placebo 2 capsules three times per day in addition to post surgical analgesic medication. Receives: Drug: Theramine- like placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (3)
Change in Visual Analogue Scale Evaluation (VASE)
Measured: 28 days
Change in second Knee pain scale.
Measured: 28 Days
Time to discontinuation of analgesic.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Unable to recruit patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targeted Medical Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory V. Hickman, MD, Principal investigator, Andrews-Paulos Research & Education Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534286
- Sponsor's protocol ID
- 0201302
- Status last verified
- May 2016
- First submitted
- 13 Feb 2012
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Too small data set to draw any conclusions
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01534286
- Acronym / sponsor ID
- 0201302
- Conditions
- Knee Pain, Knee Chondroplasty
- Keywords
- Prescription Medical Food, Theramine, Knee surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit patients
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Targeted Medical PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Theramine | Active comparator | Drug: TheramineTheramine 2 capsules three times per day in addition to post surgical analgesic medication. |
| Theramine-like Placebo | Placebo comparator | Drug: Theramine- like placeboTheramine-like placebo 2 capsules three times per day in addition to post surgical analgesic medication. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheramineTheramine 2 capsules 3 times per day | Drug | Theramine |
| Theramine- like placeboTheramine-like placebo capsules 2 three times daily | Drug | Theramine-like Placebo |
Primary outcome
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.
3 secondary outcomes
Change in Visual Analogue Scale Evaluation (VASE)
Time frame: 28 days
Change in second Knee pain scale.
Time frame: 28 Days
Time to discontinuation of analgesic.
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Unable to recruit patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Too small data set to draw any conclusions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory V. Hickman, MD principal investigator
Andrews-Paulos Research & Education Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Theramine in people with Knee Pain and Knee Chondroplasty, run by Targeted Medical Pharma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose reduction of analgesic. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.