CTRI/2026/07/113696进行中（未招募）3 期
Corticosteroid Lumbar Epidural Analgesia for Radicular Pain (C.L.E.A.R) 2 - A Randomized, Double-blind, Active Comparator and Placebo-controlled, Multicenter, Safety and Efficacy Trial of SP-102 in Participants with Moderate to Severe Lumbosacral Radicular Pain - C.L.E.A.R 2
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 755
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Eligibility Criteria
- •Main Inclusion Criteria
- •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.
- •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
- •Agrees to follow study-specific medication requirements.
- •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.
- •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
- •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.
排除标准
- •Has a body mass index greater than or equal to forty kilograms per square meter.
- •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.
- •Has ever had lumbosacral back surgery or plans to undergo spine surgical intervention while participating in the study.
- •Has been diagnosed with insulin dependent diabetes mellitus.
- •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.
- •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.
- •Has any contraindication to performing magnetic resonance imaging, such as coronary pacemakers, implantable cardioverter defibrillators, metallic foreign bodies, neurostimulators, or spinal cord stimulators.
- •Has a history of malignancy or evidence of malignancy within five years of the Screening Visit.
- •Has significant motor impairment.
- •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.
- •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.
研究者
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