4.0 STUDY DESCRIPTION

Transcription

1 4.0 STUDY DESCRIPTION 4.1 Subject Selection A sufficient number of subjects will be enrolled to ensure that a total of 800 evaluable subjects complete the study Inclusion Criteria 1. The patient is a male or female of the legal age of consent. 2. If the patient is a female of childbearing potential, has been using adequate contraception since her last menses and will use adequate contraception during the study, is not lactating, and has had a negative serum pregnancy test within 24 hours prior to receiving the first dose of study medication. 3. Agrees to participate in this study by providing written Informed Consent. 4. The patient has been diagnosed as having OA of the hip or knee by ACR criteria (ACR Criteria refer to Appendix A Table 5) of at least six months duration. 5. One joint must be selected as the index joint for further evaluation during the study. 6. The patient must be experiencing moderate to severe symptoms related to OA in the index joint defined as follows: Physician's OA Assessment of Arthritis must be fair, poor or very poor. Patient's OA Assessment of Arthritis must be fair, poor or very poor. Hip or Knee Pain while Standing must be moderate, severe or very severe. 7. The patient has a documented history of at least one of the foiiowing: Gastric, pyloric channel or duodenal ulcer. An ulcer is defined as any break in the mucosa of at least 3 mm in diameter with unequivocal depth. Endoscopically confirmed ten or more erosions in the stomach, or ten or more erosions in the duodenum. An erosion is defined as any break in the mucosa without depth.

2 4.1.2 Exclusion Criteria 1. The patient has any inflammatory arthritis other than OA, fibromyalgia or acute joint trauma at the site of OA. 2. The patient has taken the following medications within 30 days prior to the first dose of study medication or is anticipated to require any of the following medications during the course of the study: corticosteroids (including intraarticular injections) and anticoagulants. 3. The patient has taken any NSAIDs or any analgesic within seven days prior to the Baseline Arthritis Assessments. (Subjects who have been taking <325 mg aspirin per day for cardiovascular prophylaxis for at least 30 days prior to the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study). 4. The patient is scheduled to have an arthroscopy or joint lavage of the index joint or joint replacement surgery. 5. The patient has active GI disease (e.g. inflammatory bowel disease) or has an esophageal, gastric, pyloric channel or duodenal ulcer (an ulcer is any break in the mucosa at least 3 mm in diameter with unequivocal depth) or more than ten erosions in the stomach or more than ten erosions in the duodenum. 6. The patient is required to receive any anti-ulcer therapy during the course of the study. 7. The patient has a history of any gastric or duodenal surgeries other than a simple oversew. 8. The patient has a chronic or acute renal or hepatic disorder, significant coagulation defect, malignancy of any type, or history of a malignancy. (Subjects who have a history of basal cell carcinoma that has been surgically removed are acceptable. Subjects with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years prior to study enrollment are also acceptable). 9. Any subject who has received any investigational medication within 30 days prior to the first dose of study medication or who is scheduled to receive an investigational drug other than study medication during the course of this study. 10. Known hypersensitivity to mabune, Feelsonice, or mulpre or other prostaglandins, including a history or presence of nasal polyps, bronchospasm and urticaria syndrome induced by NSAIDs. 11. Previously admitted to the study.

3 Inclusion Criteria 1. The patient is a male or female of the legal age of consent. 2. If the patient is a female of childbearing potential, has been using adequate contraception since her last menses and will use adequate contraception during the study, is not lactating, and has had a negative serum pregnancy test within 24 hours prior to receiving the first dose of study medication. 3. Agrees to participate in this study by providing written Informed Consent. 4. The patient has been diagnosed as having OA of the hip or knee by ACR criteria of at least six months duration. 5. One joint must be selected as the index joint for further evaluation during the study. 6. The patient must be experiencing moderate to severe symptoms related to OA in the index joint defined as follows: Physician s OA Assessment of Arthritis must be fair, poor or very poor; Patient s OA Assessment of Arthritis must be fair, poor or very poor; Hip or Knee Pain while standing must be moderate, severe or very severe. 7. The patient has documented history of at least one of the following: Gastric, pyloric channel or duodenal ulcer (an ulcer is defined as any break in the mucosa of at least 3 mm in diameter with unequivocal depth); Endoscopically, confirmed ten or more erosions in the stomach, or ten or more erosions in the duodenum (an erosion is defined as any break in the mucosa without depth).

4 Exclusion Criteria A candidate will be excluded from this study if he/she satisfies any one of the criteria listed below: 1. The patient has any inflammatory arthritis other than OA, fibromyalgia or acute joint trauma at the site of OA. 2. The patient has taken the following medications within 30 days prior to the first dose of study medication or is anticipated to require any of the following medications during the course of the study: a. corticosteroids (including intra articular injections); b. anticoagulants. 3. The patient has taken any NSAIDs or any analgesic within three days prior to the Baseline Arthritis Assessments. (Patients who have been taking <325 mg aspirin per day for cardiovascular prophylaxis for at least 30 days prior to the first dose of study medication will be allowed to continue their aspirin regimen for the duration of the study). 4. The patient is scheduled to have an arthroscopy or joint lavage of the index joint or joint replacement surgery. 5. The patient has active GI disease (e.g. inflammatory bowel disease) or has an esophageal, gastric, pyloric channel or duodenal ulcer (an ulcer is any break in the mucosa at least 3 mm in diameter with unequivocal depth) or more than ten erosions in the stomach or more than ten erosions in the duodenum. 6. The patient is required to receive any anti-ulcer therapy during the course of the study. 7. The patient has a history of any gastric or duodenal surgery other than a simple oversew.

5 Exclusion Criteria 8. The patient has a chronic or acute renal or hepatic disorder, significant coagulation defect, malignancy of any type, or history of a malignancy. (Patients who have a history of basal cell carcinoma that has been surgically removed are acceptable. Patients with a history of other malignancies that have been surgically removed and who have no evidence of recurrence for at least five years prior to study enrollment are also acceptable). 9. Any subject who has received any investigational medication within 30 days prior to the first dose of study medication or who is scheduled to receive an investigational drug other than study medication during the course of this study. 10. Known hypersensitivity to mabune, Feelsonice, or mulpre or other prostaglandins, including a history or presence of nasal polyps, bronchospasm and urticaria syndrome induced by NSAIDS. 11. Previously, admitted to the study Investigator s Signature Jane Mask, MD Date Oct.20, 2001