Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory D… (NCT00984815) | Clinical Trial Compass
CompletedPhase 3
Safety Study of HZT-501 in Patients Who Require Long-Term Daily Non-steroidal Anti-inflammatory Drug Treatment
United States86 participantsStarted 2009-09
Plain-language summary
The purpose of this study is to evaluate the safety of long-term treatment with HZT-501, a fixed-dose combination oral tablet of 800 mg ibuprofen and 26.6 mg famotidine for patients that require long-term NSAID treatment.
Who can participate
Age range40 Years – 80 Years
SexALL
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Inclusion Criteria:
* Patient is capable of understanding the purpose and risks of the study and is able to provide written Informed Consent.
* Patient is male or female, aged 40 to 80 years of age.
* Patient is expected to require daily administration of an NSAID for at least the coming year for conditions including but not limited to: osteoarthritis, rheumatoid arthritis, chronic low back pain, chronic regional pain syndrome, chronic soft tissue pain.
* Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the entire study period.
* Patient is willing and able to comply with the prescribed treatment protocol and evaluations.
Exclusion Criteria:
* Patient has a history of or experienced any of the following:
* NSAID-associated and/or primary peptic ulcer disease-associated serious gastrointestinal complications such as perforation of ulcers, gastric outlet obstruction due to ulcers, and/or acute gastrointestinal bleeding
* NSAID-induced asthma exacerbation, acute renal failure, interstitial nephritis, and/or hepatitis
* Malignant disease of the gastrointestinal tract
* Erosive esophagitis
* Coronary artery bypass graft (CABG) surgery within the 14 days prior to study Day 0
* Uncontrolled diabetes mellitus as evidenced by Hemoglobin A1c \> 7%
* Known history of human immunodeficiency virus (HIV), hepatitis B, and/or hepatitis C
* Patient has active cardi…
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events