Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00584870 | RN624 In Adult Patients With Chronic Low Back Pain | PHASE2 | COMPLETED | 220 | — | — | Jul 5, 2007 | Sep 2, 2008 | Jul 12, 2021 | 38 | United States |
Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain). Baseline value was calculated as mean of the scores over 5-day prior to randomization (initial pain assessment period). Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
| Arm | Type | Description |
|---|---|---|
| Naproxen | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| RN624 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Naproxen | DRUG | Oral naproxen 500 mg twice daily for Weeks 1-12. |
| Placebo | DRUG | Single IV infusion of placebo on Day 1 and placebo for naproxen twice daily for Weeks 1-12. |
| PF-04383119 (RN624) | DRUG | Single IV infusion of 200 micrograms/kg RN624 on Day 1 |
Inclusion Criteria: * Male or female of any race, \>18 years of age and have BMI ≤39 kg/m2 * Present with duration of chronic low back pain of ≥3 months requiring regular use of analgesic medication (\>4 days per week for the past month) * Primary location of low back pain is between the 12th thora...