Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-24 @ 6:33 PM
NCT ID:
NCT01510457
Eligibility Criteria:
Inclusion Criteria:
* Knee pain and osteophytes on radiographs OR
* Knee pain plus patient age of 40 years or older, morning stiffness lasting 30 minutes or less, and crepitus (cracking sound) during motion
* Experiences chronic pain for 6 months or longer
* Average pain rating of worse knee is equal to 4 or greater on a 0-10 scale
* If female, is not pregnant or breast feeding, and not currently attempting to conceive; if of childbearing potential, use of a highly effective method of birth control (as determined by Pl)
* Able to walk at least ½ a city block a day, and agrees to try and slowly increase that over the course of study
* Able to read and speak English and provide informed consent
* Able to understand and comply with all data collection methodology including electronic diary
* Subject agrees to 1) continue their stable drug regimen with no changes during the course of study, 2) only use Tylenol 325 mg of tablets (a maximum of 8 tablets a day) for breakthrough pain, and 3) not use Tylenol or any other pain medicines 12 hours before testing.
Exclusion Criteria:
* Subject takes SNRIs (Savella, Cymbalta, Venlafaxine) or other neuroamine re-uptake blockers for mood disorders
* Subject is allergic to SSRIs, SNRIs, or milnacipran
* Subject has severe or untreated psychiatric disturbance (e.g. mania, depression, anxiety, substance dependence)
* Subject is medicated with 'triptans, MAOIs, SSRIs, other SNRIs, tricyclic or heterocyclic antidepressants, lithium, epinephrine, norepinephrine, clonidine or digoxin during the trial
* Subject has a clinical diagnosis of fibromyalgia
* Subject has severe ongoing or unaddressed medical conditions (e.g. Renal or Hepatic disease \[creatinine\>1.5 ml/dl; AST or ALT\> 3x normal limit\], uncontrolled hypertension, severe cardiac rate or rhythm disorders, rheumatologic disease (e.g. polymyalgia rheumatica), narrow angle glaucoma, hyponatremia, clotting disorders, uncontrolled seizure disorder or urinary retention)
* Subject has cardiac implants
* Subject has a knee replacement
* Subject plans to start new pain treatments or therapies during the study (e.g. new pain medication, injections, PT, surgery)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT01510457
Study Brief:
Protocol Section:
NCT01510457