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.
A 2-part study. In the first part the safety, tolerability and pharmacokinetics will be assessed in up to 6 participants. In the second part, the safety, tolerability and efficacy of PP353 will be assessed in up to 40 participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
43
Gildhøj Privathospital København
Copenhagen, Denmark
CGM Research Trust
Christchurch, New Zealand
Hospital Vithas Granada
Granada, Spain
Hospital Universitario LA PAZ
Incidence of Adverse Events
All causality Treatment Emergent Adverse Events. Any event that was not present prior to the initiation of the treatment, or any event that was already present but increased in intensity or frequency following treatment, was recorded as a treatment-emergent adverse event
Time frame: 0 to 12 months
Change From Baseline in Low Back Pain Numerical Rating Scale (LBP NRS) Score
Each question will be assessed by the subject on an 11-point scale with 0 = "no pain" and 10 = "the worst possible pain you can imagine." A lower score indicates less pain. The Low Back Pain Numerical Rating score throughout this protocol is defined as the average of the score of the three questions: 1. Low back pain intensity now 2. Worst low back pain intensity in the last 14 days 3. Average low back pain intensity over the last 14 days Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.
Time frame: 12 months
Change From Baseline in Roland Morris Disability Questionnaire-23 Score
The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.
Time frame: 12 months
Clinically Relevant Improvement (≥30%) in RMDQ-23
The Roland Morris Disability Questionnaire (RMDQ)-23 is a self-administered disability measure consisting of 23 questions. Participants are asked to read a list of 23 sentences and answer "yes" or "no" to each question depending on how the participant feels each sentence describes them today. . The total number of "yes" responses gives a score from 0 to 23. A lower score indicates less disability. Participants required a score of at least 9 to enter the study Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.
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Madrid, Spain
Royal Preston Hospital
Preston, Lancashire, United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, Oxford, United Kingdom
University Hospital Of Wales
Cardiff, Wales, United Kingdom
University Hospital Coventry & Warwickshire
Coventry, United Kingdom
Leeds General Infirmary
Leeds, United Kingdom
University Hospital Southampton Nhs Foundation Trust
Southampton, United Kingdom
Time frame: 12 months
Change From Baseline in Oswestry Disability Index
The ODI is a subject-completed questionnaire which gives a subjective percentage score of level of function (disability) in activities of daily living. A lower score indicates less disability. Scores are interpreted as follows: 0-20%: minimal disability 21-40%: moderate disability 41-60%: severe disability 61-80% crippled 81-100%: bed-bound Part A PP353 was an open label arm (3 participants): this outcome measure was not determined. No summary analyses were conducted for efficacy in Part A.
Time frame: 12 months