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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT01421160
Eligibility Criteria:
Inclusion Criteria:
1. Presence of joint pain of perceived inflammatory and non-inflammatory origin for more than six months. More specifically:
* Subjects with osteoarthritis (OA) of the knee will be preferred for inclusion in this study.
* Subjects with other joint pain history will be included pursuant on approval from Dr. Miller or Dr. Pema.
2. Age 21 to 80 years old and otherwise in good health (excluding the joint pain).
3. Able to understand and comply with the assigned urine alkalinization instructions.
4. Has a working and reliable telephone number for continued contact as necessary during the study.
5. Ability to obtain X-rays of the affected joint. Imaging of the painful joint will be necessary at the beginning of the study for baseline considerations; if images from the last 6 months are available, no new imaging would be necessary.
6. Ability to obtain lab tests (Complete Blood Count and Comprehensive Metabolic Panel) or can obtain documentation of recent lab tests that have been taken within one month prior to enrollment.
7. Ability to obtain lab tests at 3 and 6 months during participation in the study.
Exclusion Criteria:
1. Presence of joint pain with known joint osseous changes.
2. Pregnant or lactating women will not be enrolled in the study.
3. Positive medical history of:
* Diabetes
* Neuropathies
* Gout
* Psychiatric diseases and conditions, including anxiety, depression, PTSD, distress
* Psychosocial abnormalities
* Dementia or other memory disturbances
* Alcoholism or substance abuse
* Renal failure and/or abnormal renal function (kidney disease or dysfunction). Specifically, Creatinine (Creat) values that are over 1.2mg/dL and Urea Nitrogen (BUN) values that are over 22mg/dL are considered abnormal.
* No history of cardiovascular disease, intestinal angina or arrhythmias
* No history of sodium restrictions
* Pt. should not be taking medications which produce pain such as angiotensin converting enzyme (ACE) inhibitors and Statins (Lisinopril, Quinapril, Ramipril)
4. Does not have reliable telephone communication.
5. Does not have the ability to obtain an X-ray and does not have the ability to obtain documentation of a recent X-ray within the last six months.
6. Does not have the ability to obtain lab tests (Complete Blood Count and Comprehensive Metabolic Panel) and does not have the ability to obtain documentation of recent lab tests that have been taken within one month prior to enrollment.
7. Does not have the ability to obtain lab tests at 3 and 6 months during participation in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT01421160
Study Brief:
Protocol Section:
NCT01421160