Trial · NCT03246399
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability: treatment emergent adverse events (TEAEs) | Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by TEAEs during the entire treatment and observation period |
| Primary | Safety and tolerability: change from baseline in electrocardiogram (ECG) parameters | Baseline and Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in ECG parameters |
| Primary | Safety and tolerability: change from baseline in physical examination | Baseline and Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in physical examination (number of subjects with clinically significant change in physical examination) |
| Primary | Safety and tolerability: change from baseline in clinical laboratory tests | Baseline and Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in clinical laboratory tests (number of subjects with clinically significant changes in laboratory test parameters) |
| Primary | Safety and tolerability: change from baseline in vital signs | Baseline and Day 180 | Evaluate the safety and tolerability of SM04690 Injectable Suspension as measured by change from baseline in vital signs (number of subjects with clinically significant changes in vital signs) |
| Primary | Incidence of dose-limiting toxicities (DLTs) | Day 180 | Evaluate incidence and severity of DLTs in each cohort |
| Primary | Pharmacokinetics (PK) of SM04690: Cmax | Day 1 | Maximum plasma concentration (Cmax) estimate for a single intradiscal injection of SM04690 Injectable Suspension |
| Primary | PK of SM04690: tmax | Day 1 | Time to Cmax estimate for a single intradiscal injection of SM04690 Injectable Suspension |
| Primary | PK of SM04690: AUC | Day 1 | Area under the plasma-concentration time curve (AUC) estimate for a single intradiscal injection of SM04690 Injectable Suspension |
| Primary | PK of SM04690: half-life | Day 1 | Plasma terminal phase half-life estimate for a single intradiscal injection of SM04690 Injectable Suspension |
| Secondary | Change in spine bone mineral density | Baseline and Day 180 | Evaluate change from baseline spine bone mineral density as measured by dual-energy x-ray absorptiometry (DXA) |
| Secondary | Change in hip bone mineral density | Baseline and Day 180 | Evaluate change from baseline hip bone mineral density as measured by DXA |
| Other | Change in lumbar back pain | Baseline and Day 180 | Evaluate change from baseline lumbar back pain using the Visual Analog Scale (VAS) |
| Other | Change in disability | Baseline and Day 180 | Evaluate change from baseline disability as measured by Oswestry disability index (ODI) |
| Other | Change in disease activity by physician assessment | Baseline and Day 180 | Evaluate change from baseline disease activity using Physician Global Assessment (PGA) |
| Other | Change in treated intervertebral discs | Baseline and Day 180 | Evaluate change from baseline in treated intervertebral discs by modified Pfirrmann grade using Magnetic Resonance Imaging (MRI) |
| Other | Change in disc space height | Baseline and Day 180 | Evaluate change from baseline in disc space height by radiograph |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03246399/registered