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Corticosteroid Lumbar Epidural Analgesia for Radiculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372161
Recruitment Status : Completed
First Posted : December 13, 2017
Results First Posted : September 19, 2022
Last Update Posted : September 19, 2022
Sponsor:
Collaborators:
Worldwide Clinical Trials
Semnur Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Scilex Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lumbosacral Radicular Pain
Interventions Drug: SP-102
Drug: Placebo
Enrollment 401
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SP-102 Placebo
Hide Arm/Group Description

SP-102

SP-102: injection

Placebo

Placebo: injection

Period Title: Overall Study
Started 202 199
Completed 193 192
Not Completed 9 7
Arm/Group Title SP-102 Placebo Total
Hide Arm/Group Description

SP-102

SP-102: injection

Placebo

Placebo: injection

Total of all reporting groups
Overall Number of Baseline Participants 202 199 401
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 202 participants 199 participants 401 participants
51.2  (9.83) 51.7  (10.36) 51.4  (10.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 199 participants 401 participants
Female
116
  57.4%
122
  61.3%
238
  59.4%
Male
86
  42.6%
77
  38.7%
163
  40.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 199 participants 401 participants
Hispanic or Latino
34
  16.8%
35
  17.6%
69
  17.2%
Not Hispanic or Latino
168
  83.2%
164
  82.4%
332
  82.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 202 participants 199 participants 401 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   2.0%
3
   1.5%
7
   1.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
37
  18.3%
33
  16.6%
70
  17.5%
White
160
  79.2%
162
  81.4%
322
  80.3%
More than one race
1
   0.5%
1
   0.5%
2
   0.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Mean Change From Baseline (Day 1) to Week 4 in the Mean Numeric Pain Rating Scale (NPRS) Average Pain Score in the Affected Leg
Hide Description The NPRS is an 11-point scale (0 to 10-point scale where 0 was no pain and 10 was worst pain imaginable) that allowed the subject to rate the severity of their pain intensity at various points in time.
Time Frame Baseline, 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SP-102 Placebo
Hide Arm/Group Description:
SP-102: injection
Placebo: injection
Overall Number of Participants Analyzed 148 184
Mean (Standard Deviation)
Unit of Measure: Change in score on a scale from baseline
-2.34  (1.842) -1.16  (1.723)
2.Secondary Outcome
Title Mean Change From Baseline (Day 1) to Week 4 in the Oswestry Disability Index Score (ODI)
Hide Description The ODI is the gold standard for measuring degree of disability and estimating quality of life in a person with low back pain. The ODI is a questionnaire completed by the subject that assesses10 topics: intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Each question was scored on a scale of 0-5 with 0 indicating the least amount of disability and 5 indicating the most severe disability. The scores for all questions answered were summed, then multiplied by 2 to obtain the index (range 0 to 100). Zero was equated with no disability and 100 was the maximum disability possible.
Time Frame Baseline, 4 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SP-102 Placebo
Hide Arm/Group Description:
SP-102: injection
Placebo: injection
Overall Number of Participants Analyzed 147 177
Mean (Standard Deviation)
Unit of Measure: Change in score on a scale from baseline
-10.89  (14.906) -4.76  (12.896)
Time Frame 4 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SP-102 Placebo
Hide Arm/Group Description SP-102: injection Placebo: injection
All-Cause Mortality
SP-102 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/202 (0.00%)   1/199 (0.50%) 
Hide Serious Adverse Events
SP-102 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/202 (0.00%)   2/199 (1.01%) 
Cardiac disorders     
Cardiac arrest  1  0/202 (0.00%)  1/199 (0.50%) 
Infections and infestations     
COVID-19 pneumonia  1  0/202 (0.00%)  1/199 (0.50%) 
1
Term from vocabulary, MedDRA (24.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SP-102 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   60/202 (29.70%)   42/199 (21.11%) 
Cardiac disorders     
Cardiac arrest  1  0/202 (0.00%)  1/199 (0.50%) 
Cardiomyopathy  1  1/202 (0.50%)  0/199 (0.00%) 
Palpitations  1  1/202 (0.50%)  1/199 (0.50%) 
Ear and labyrinth disorders     
Vertigo positional  1  1/202 (0.50%)  0/199 (0.00%) 
Eye disorders     
Vision blurred  1  1/202 (0.50%)  0/199 (0.00%) 
Gastrointestinal disorders     
Abdominal distension  1  1/202 (0.50%)  0/199 (0.00%) 
Diarrhoea  1  0/202 (0.00%)  1/199 (0.50%) 
Dyspepsia  1  2/202 (0.99%)  0/199 (0.00%) 
Hiatus hernia  1  1/202 (0.50%)  0/199 (0.00%) 
Nausea  1  3/202 (1.49%)  1/199 (0.50%) 
Toothache  1  2/202 (0.99%)  1/199 (0.50%) 
Vomiting  1  3/202 (1.49%)  0/199 (0.00%) 
General disorders     
Chills  1  0/202 (0.00%)  1/199 (0.50%) 
Fatigue  1  1/202 (0.50%)  0/199 (0.00%) 
Feeling hot  1  1/202 (0.50%)  1/199 (0.50%) 
Gait disturbance  1  1/202 (0.50%)  0/199 (0.00%) 
Injection site pain  1  4/202 (1.98%)  0/199 (0.00%) 
Non-cardiac chest pain  1  0/202 (0.00%)  1/199 (0.50%) 
Pain  1  1/202 (0.50%)  0/199 (0.00%) 
Peripheral swelling  1  0/202 (0.00%)  1/199 (0.50%) 
Infections and infestations     
Abscess  1  1/202 (0.50%)  0/199 (0.00%) 
Bronchitis  1  1/202 (0.50%)  2/199 (1.01%) 
COVID-19  1  1/202 (0.50%)  1/199 (0.50%) 
COVID-19 pneumonia  1  0/202 (0.00%)  1/199 (0.50%) 
Dacryocystitis  1  1/202 (0.50%)  0/199 (0.00%) 
Gastroenteritis  1  0/202 (0.00%)  1/199 (0.50%) 
Influenza  1  0/202 (0.00%)  1/199 (0.50%) 
Labyrinthitis  1  1/202 (0.50%)  0/199 (0.00%) 
Pharyngitis streptococcal  1  0/202 (0.00%)  1/199 (0.50%) 
Pyelonephritis  1  0/202 (0.00%)  1/199 (0.50%) 
Respiratory tract infection  1  1/202 (0.50%)  0/199 (0.00%) 
Rhinovirus infection  1  0/202 (0.00%)  1/199 (0.50%) 
Sinusitis  1  4/202 (1.98%)  0/199 (0.00%) 
Tooth abscess  1  1/202 (0.50%)  1/199 (0.50%) 
Upper respiratory tract infection  1  2/202 (0.99%)  4/199 (2.01%) 
Urinary tract infection  1  2/202 (0.99%)  3/199 (1.51%) 
Injury, poisoning and procedural complications     
Arthropod sting  1  1/202 (0.50%)  0/199 (0.00%) 
Contusion  1  0/202 (0.00%)  1/199 (0.50%) 
Fall  1  0/202 (0.00%)  1/199 (0.50%) 
Ligament sprain  1  1/202 (0.50%)  1/199 (0.50%) 
Post procedural complication  1  1/202 (0.50%)  0/199 (0.00%) 
Procedural pain  1  2/202 (0.99%)  1/199 (0.50%) 
Soft tissue injury  1  0/202 (0.00%)  1/199 (0.50%) 
Tooth fracture  1  2/202 (0.99%)  0/199 (0.00%) 
Traumatic haematoma  1  0/202 (0.00%)  1/199 (0.50%) 
Upper limb fracture  1  0/202 (0.00%)  1/199 (0.50%) 
Investigations     
Blood lactate dehydrogenase increased  1  1/202 (0.50%)  1/199 (0.50%) 
Blood pressure increased  1  2/202 (0.99%)  0/199 (0.00%) 
Cardiac murmur  1  0/202 (0.00%)  1/199 (0.50%) 
Gamma-glutamyltransferase increased  1  0/202 (0.00%)  1/199 (0.50%) 
Hepatic enzyme increased  1  1/202 (0.50%)  0/199 (0.00%) 
SARS-CoV-2 test positive  1  1/202 (0.50%)  0/199 (0.00%) 
Weight increased  1  0/202 (0.00%)  1/199 (0.50%) 
Metabolism and nutrition disorders     
Type 2 diabetes mellitus  1  1/202 (0.50%)  0/199 (0.00%) 
Vitamin D deficiency  1  1/202 (0.50%)  0/199 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/202 (1.49%)  1/199 (0.50%) 
Back pain  1  1/202 (0.50%)  0/199 (0.00%) 
Flank pain  1  1/202 (0.50%)  0/199 (0.00%) 
Muscle tightness  1  1/202 (0.50%)  0/199 (0.00%) 
Musculoskeletal chest pain  1  0/202 (0.00%)  1/199 (0.50%) 
Pain in extremity  1  2/202 (0.99%)  2/199 (1.01%) 
Nervous system disorders     
Burning sensation  1  1/202 (0.50%)  0/199 (0.00%) 
Dizziness  1  2/202 (0.99%)  0/199 (0.00%) 
Dysgeusia  1  1/202 (0.50%)  0/199 (0.00%) 
Formication  1  0/202 (0.00%)  1/199 (0.50%) 
Headache  1  13/202 (6.44%)  11/199 (5.53%) 
Hypoaesthesia  1  0/202 (0.00%)  1/199 (0.50%) 
Lethargy  1  0/202 (0.00%)  1/199 (0.50%) 
Migraine  1  3/202 (1.49%)  0/199 (0.00%) 
Paraesthesia  1  0/202 (0.00%)  1/199 (0.50%) 
Presyncope  1  1/202 (0.50%)  0/199 (0.00%) 
Radicular pain  1  1/202 (0.50%)  1/199 (0.50%) 
Syncope  1  1/202 (0.50%)  0/199 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Pregnancy  1  1/202 (0.50%)  0/199 (0.00%) 
Psychiatric disorders     
Anxiety  1  2/202 (0.99%)  1/199 (0.50%) 
Depression  1  0/202 (0.00%)  1/199 (0.50%) 
Insomnia  1  0/202 (0.00%)  1/199 (0.50%) 
Restlessness  1  0/202 (0.00%)  1/199 (0.50%) 
Renal and urinary disorders     
Stress urinary incontinence  1  1/202 (0.50%)  0/199 (0.00%) 
Ureterolithiasis  1  0/202 (0.00%)  1/199 (0.50%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/202 (0.00%)  2/199 (1.01%) 
Hiccups  1  1/202 (0.50%)  0/199 (0.00%) 
Skin and subcutaneous tissue disorders     
Dermatitis contact  1  1/202 (0.50%)  0/199 (0.00%) 
Hyperhidrosis  1  0/202 (0.00%)  1/199 (0.50%) 
Pruritus  1  1/202 (0.50%)  0/199 (0.00%) 
Rash  1  1/202 (0.50%)  0/199 (0.00%) 
Vascular disorders     
Accelerated hypertension  1  0/202 (0.00%)  1/199 (0.50%) 
Flushing  1  1/202 (0.50%)  0/199 (0.00%) 
Hot flush  1  1/202 (0.50%)  0/199 (0.00%) 
Hypertension  1  4/202 (1.98%)  1/199 (0.50%) 
1
Term from vocabulary, MedDRA (24.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor has the right to first publication of the results of the study. Following the first publication, PIs may publish study data or results; however, the proposed publication must be submitted to the Sponsor for review and approval in writing at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study Data.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director Clinical Operations
Organization: Scilex Pharmaceuticals, Inc.
Phone: (650) 386-6709
EMail: cambrose@scilexpharma.com
Layout table for additonal information
Responsible Party: Scilex Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03372161    
Other Study ID Numbers: SP-102-02
First Submitted: December 8, 2017
First Posted: December 13, 2017
Results First Submitted: August 19, 2022
Results First Posted: September 19, 2022
Last Update Posted: September 19, 2022