Phase 2
Completed N=220
RN624 In Adult Patients With Chronic Low Back Pain
Source: ClinicalTrials.gov NCT00584870 ↗Enrolled (actual)
220
Serious AEs
0.9%
Results posted
Jun 2021
Primary outcomePrimary: Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 — 6.48; 6.65; 6.67; -3.58 units on a scale — p=0.001
Summary
The primary objective of this study is to evaluate the analgesic efficacy of RN624 compared with placebo and compared with naproxen in the treatment of adult patients with chronic low back pain.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 6 |
6.48; 6.65; 6.67; -3.58; -2.69; -2.16 | 0.001 sig |
| SECONDARY Change From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score at Week 1, 2, 4, 8 and 12 |
-2.41; -2.18; -1.34; -2.25; -2.40; -1.92 | — |
| SECONDARY Change From Baseline in Average Low Back Pain Intensity (LBPI) Score Over Weeks 1 to 4, 1 to 8, 1 to 12, 5 to 8, and 5 to 12 |
-2.59; -2.35; -1.83; -2.86; -2.47; -1.97 | — |
| SECONDARY Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Worst Pain and Average Pain at Week 1, 2, 4, 6, 8 and 12 |
6.89; 7.02; 7.29; 5.99; 6.18; 6.54 | — |
| SECONDARY Number of Participants With Average Low Back Pain Intensity (LBPI) Score of 2 or Less |
18; 13; 2; 20; 19; 4 | — |
| SECONDARY Number of Participants With Cumulative Percent (%) Reduction From Baseline in Average Low Back Pain Intensity (LBPI) Score at Week 6 |
79; 77; 34; 75; 72; 29 | — |
| SECONDARY Number of Participants With at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score |
71; 60; 26; 62; 50; 20 | — |
| SECONDARY Number of Participants With at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score |
46; 45; 8; 28; 26; 5 | — |
| SECONDARY Time to Achieve at Least 30% and 50% Sustained Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score |
8; 7; 17; 18; 41; 65 | — |
| SECONDARY Total Duration of at Least 30% and 50% Reduction From Baseline in Daily Average Low Back Pain Intensity (LBPI) Score |
43.91; 38.81; 33.13; 33.21; 27.58; 22.08 | — |
| SECONDARY Change From Baseline in Roland-Morris Disability Questionnaire Total Score at Week 1, 2, 4, 6, 8, and 12 |
12.33; 12.36; 13.68; -5.21; -3.69; -3.76 | — |
| SECONDARY Change From Baseline in Modified Brief Pain Inventory-short Form (mBPI-sf) Scores for Pain Interference With Function (Composite Score), General Activity, Walking Ability, Normal Work and Sleep Scores at Week 1, 2, 4, 6, 8 and 12 |
4.81; 5.43; 5.29; 5.55; 5.83; 5.49 | — |
| SECONDARY Number of Participants With Change From Baseline in Patient's Global Assessment of Low Back Pain (Disease Activity) Score at Week 1, 2, 4, 6, 8 and 12 |
1; 0; 0; 1; 2; 1 | — |
| SECONDARY Number of Participants With Each Response Level of Patient's Global Evaluation of Study Medication |
7; 13; 12; 16; 22; 11 | — |
| SECONDARY Number of Participants Who Discontinued the Study Due to Lack of Efficacy |
7; 14; 8 | — |
| SECONDARY Time to Discontinuation Due to Lack of Efficacy |
NA; NA; NA | — |
| SECONDARY Number of Participants With Chronic Low Back Pain (CLBP) Response |
33; 30; 6; 32; 34; 9 | — |
| SECONDARY Number of Participants Who Used Rescue Medications |
61; 50; 29; 65; 49; 27 | — |
| SECONDARY Duration of Rescue Medication Use |
2; 1; 1; 2; 1; 1.5 | — |
| SECONDARY Amount of Rescue Medication Taken |
2545.5; 2039.8; 2451.2; 3221.6; 2327.6; 2225.0 | — |
Eligibility Criteria
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 thoracic vertebra and the lower gluteal folds, with or without radiation into the posterior thigh, classified as Category 1 or 2 according to the classification of the Quebec Task Force in Spinal Disorders
- Must have a score of ≥4 for Low Back Pain Intensity (NRS) while on current treatment at Screening, and completes at least 4 daily pain diaries during the 5 days prior to Randomization, with an average Low Back Pain Intensity (NRS) score of ≥4
Exclusion Criteria
- Back pain due to visceral disorder (i.e. endometriosis) or Back pain due to recent major trauma (i.e. vertebral fracture, post-traumatic spondylolisthesis)
- History of lumbosacral radiculopathy, spinal stenosis associated with neurological impairment, or neurogenic claudication
- Osteoporotic compression fracture within the last 6 months
- Known history of: Rheumatoid arthritis; Seronegative spondyloarthropathy (i.e., ankylosing spondylitis, psoriatic arthritis, reactive arthritis, inflammatory bowel disease-related arthropathy); Paget's disease of spine, pelvis or femur; Fibromyalgia; Tumors or infections of the spinal cord
- Patients receiving acetaminophen only to manage their chronic low back pain
- Any uncontrolled or untreated chronic disease
Data sourced from ClinicalTrials.gov (NCT00584870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.