At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 43 enrolled
Drug / intervention
PP353 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1b Study Investigating the Safety, Tolerability and Efficacy of PP353 in the Treatment of Patients With Chronic Low Back Pain Associated With Vertebral Body Endplate Bone Oedema (Modic 1)
In Brief
A Phase 2 clinical trial evaluating PP353 and Placebo for Chronic Low-back Pain. Completed, enrolled 43 participants across 10 sites in 4 countries.
Detailed Summary
A Phase 1b study to investigate the efficacy of PP353 compared to placebo in the treatment of chronic low back pain associated with bone oedema.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Low-back Pain
CountriesDenmark, New Zealand, Spain, United Kingdom
CollaboratorsMicron Research Ltd
Timeline
Phase 2CompletedFinished
2020202120222023202420252026
Enrollment StartJan 2020
First PostedJan 2020
Primary CompletionDec 2024
TodayJul 2026
First PostedJan 23, 2020
Enrollment StartJan 20, 2020
Primary CompletionDec 9, 2024
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 6.4 years ago
Interventions
PP353drug
active administered by intradiscal injection
Placeboother
Sham injection