Health Condition 1: G55- Nerve root and plexus compressionsin diseases classified elsewhere
Conditions
Interventions
Intervention1: SP-102: Dose-10 mg
Route of administration-Transforaminal Epidural Injection
Frequency of administration-Single dose, one minute
Control Intervention1: Dexamethasone Sodium Phospha
Sponsors
Syngene International Limited
Eligibility
Inclusion criteria
Inclusion criteria: Eligibility Criteria Main Inclusion Criteria 1. Able and willing to read, write, and understand the English language and provide English language written informed consent prior to beginning any study procedures. Age 18 to 75 years-inclusive at the Screening Visit. 2. A diagnosis of lumbosacral radicular pain-sciatica present for at least 6 weeks and not more than 9 months prior to the Screening Visit. Clinical symptoms consistent with the imaging-MRI 3. Agrees to follow study-specific medication requirements. 4. If sexually active and a female of child-bearing potential or a male capable of bearing a child, agrees to use an effective method of birth control during the study. 5. Has reviewed all study specific materials and has, in the opinion of the Investigator, the abilities to understand and appropriately complete all study procedures. Day 1 Inclusion As calculated by the eDiary system, during the 7 days, D-7 to D-1 immediately prior to the Baseline Visit, the participant a. Completed the current, worst, and daily average NPRS scores-in the affected leg, non-affected leg, and lower back, in the eDiary on at least 6 out of the 7 days during the Baseline Period. b. Meets the NPRS average daily pain score criteria, c. Has a mean-at Baseline Visit, NPRS worst pain score in the affected leg that is greater than the mean worst pain score in lower back. Participant continues to demonstrate a clear understanding of how to complete the eDiary. Participant remains an appropriate candidate for trial participation in the opinion of the Investigator. Participant continues to meet all the screening inclusion criteria and none of the exclusion criteria.
Exclusion criteria
Exclusion criteria: 1. Has a body mass index greater than or equal to forty kilograms per square meter. 2. Has radiologic evidence of a condition that would compromise study outcomes, including the following: a. Spinal cord tumor, whether intradural or extradural, or spinal cord hematoma. b. Epidural abscess or intrathecal abscess. c. Systemic infection. 3. Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while participating in the study. 4. Has been diagnosed with insulin dependent diabetes mellitus. 5. Presence of any other disorder, condition, or circumstance, including secondary gain, that in the opinion of the Investigator has the potential to prevent study completion and or to have a confounding effect on outcome assessments. 6. Use of any investigational drug and or investigational device within thirty days, or is scheduled to receive an investigational drug other than the blinded study drug during this study. 7. Has any contraindication to performing magnetic resonance imaging, such as coronary pacemakers, implantable cardioverter defibrillators, metallic foreign bodies, neurostimulators, or spinal cord stimulators. 8. Has a history of malignancy or evidence of malignancy within five years of the Screening Visit. 9. Has significant motor impairment. 10. Has regular use of opioid doses greater than thirty milligrams of morphine equivalents per day for more than two days per week in the thirty days prior to the Screening Visit. 11. Involvement in an ongoing workers compensation claim, disability claim, or litigation related to any pain problem, receiving payments for a settled claim, awaiting pending payment for a settled claim, or any potential secondary gain in the opinion of the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to W4 in the mean NPRS average daily pain score: The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days [D-7 to D-1] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo. Timepoint: Mean change from baseline to W4 in the mean NPRS average daily pain score: The Numeric Pain Rating Scale (NPRS) is a self-reported scale assessing average pain intensity over the past 24 hours in the affected leg. Possible scores range from 0-10 (0 is no pain, 10 is worst pain imaginable) Change from baseline (mean of the scores recorded on the 7 days [D-7 to D-1] immediately prior to the P1 Injection Day) in mean NPRS average daily pain score in the affected leg over 4 weeks (i.e., W1, W2, W3, W4) for SP-102 versus placebo. | — |
Secondary
| Measure | Time frame |
|---|---|
| The key secondary efficacy endpoint is: Mean change in ODI total score from P1 Baseline (P1 D1) to P1 W4 for SP-102 versus placebo. Timepoint: Proportion of participants with a PGIC response of Very Much Improved or Much Improved at P1 Week 4 for SP-102 versus placebo. Mean change in BPI-Pain Interference (BPI-PI) score from P1Baseline (D1) to P1 Week 4 for SP-102 versus placebo Proportion of participants with a more or equal to 30 percent improvement from P1 D1 to Week 4 in mean NPRS average daily pain score in the affected leg for SP-102 versus placebo. Proportion of participants with a more than or equal to 50 percent improvement from P1 D1 to Week 4 in mean NPRS average daily pain score in the affected leg for SP-102 versus placebo. Secondary outcomes are events, variables, or experiences that are of secondary interest or that are measured at time-points of secondary interest. A secondary outcome may involve the same event, variable, or experience as the primary outcome, but measured at time-points other than those of primary interest (e.g., Primary outcome: all-cause mortality at 5 years; Secondary outcome. all-cause mortality at 1 year, 3 years), or may involve a different event, variable, or experience altogether (e.g., Primary outcome: all-cause mortality at 5 years; Secondary outcome: hospitalization rate at 5 years). | — |
Countries
India, United States of America
Contacts
Public ContactDr. Rajalakshmi M
Syngene International Limited
Outcome results
None listed