Key Admission Criteria
| Inclusion criteria |
| A study patient had to: |
| Be 15 years of age or older |
| Have confirmed SCD (HbSS, HbSB° & Hb 5B+-Thal, Hb SC) |
| Have had at least one previous documented acute painful (crisis) episode |
| Have moderate or severe pain (typical of usual painful event) lasting at least 4 hours, but not longer than 18 hours, upon presentation to the hospital |
| Have a painful episode that required parenteral analgesics at the time of study entry |
| Have an acceptable medical history, physical examination, and clinically acceptable vital signs for an SCD patient in a painful episode |
| Exclusion criteria |
| A study patient could not: |
| Be pregnant |
| Have a clinically significant active hepatic disease (eg, total bilirubin >15 mg/dL, ALT >100 U/L, AST >100 U/L) |
| Have a clinically significant active renal disease (eg, serum creatinine >2.0 mg/dL or a calculated creatinine clearance of ≤ 50 mL/min) |
| Require daily use of narcotic analgesics for any reason |
| Have had more than 15 painful crisis episodes per year for the last 2 years |
| Have a painful episode with life-threatening complications (eg, hepatic or splenic sequestration, acute chest syndrome) |
| Have pain involving the chest, which was possibly pulmonary or cardiac in origin |
| Have had a painful event requiring hospitalization within the preceding 2 weeks |
| Have received hydroxyurea in the preceding 3 months |
| Inclusion criteria |
| A study patient had to: |
| Be 15 years of age or older |
| Have confirmed SCD (HbSS, HbSB° & Hb 5B+-Thal, Hb SC) |
| Have had at least one previous documented acute painful (crisis) episode |
| Have moderate or severe pain (typical of usual painful event) lasting at least 4 hours, but not longer than 18 hours, upon presentation to the hospital |
| Have a painful episode that required parenteral analgesics at the time of study entry |
| Have an acceptable medical history, physical examination, and clinically acceptable vital signs for an SCD patient in a painful episode |
| Exclusion criteria |
| A study patient could not: |
| Be pregnant |
| Have a clinically significant active hepatic disease (eg, total bilirubin >15 mg/dL, ALT >100 U/L, AST >100 U/L) |
| Have a clinically significant active renal disease (eg, serum creatinine >2.0 mg/dL or a calculated creatinine clearance of ≤ 50 mL/min) |
| Require daily use of narcotic analgesics for any reason |
| Have had more than 15 painful crisis episodes per year for the last 2 years |
| Have a painful episode with life-threatening complications (eg, hepatic or splenic sequestration, acute chest syndrome) |
| Have pain involving the chest, which was possibly pulmonary or cardiac in origin |
| Have had a painful event requiring hospitalization within the preceding 2 weeks |
| Have received hydroxyurea in the preceding 3 months |