Persica 002 Phase 1b PP353 vs Placebo in the Treatment of Low Back Pain
|
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04238676 |
|
Recruitment Status :
Recruiting
First Posted : January 23, 2020
Last Update Posted : June 15, 2021
|
Sponsor:
Persica Pharmaceuticals Ltd
Collaborator:
Micron Research Ltd
Information provided by (Responsible Party):
Persica Pharmaceuticals Ltd
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Low-back Pain | Drug: PP353 Drug: PP353-B | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Masking Description: | The pharmacist and injector will not be blinded to treatment allocation |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1b Study Investigating the Safety, Tolerability and Efficacy of PP353 in the Treatment of Patients With Chronic Low Back Pain Associated With Verterbral Body Endplate Bone Oedema (Modic 1) |
| Actual Study Start Date : | January 20, 2020 |
| Estimated Primary Completion Date : | May 2022 |
| Estimated Study Completion Date : | May 2022 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: PP353 |
Drug: PP353
active administered by intradiscal injection |
| Placebo Comparator: PP353-B |
Drug: PP353-B
placebo administered by intradiscal injection |
Primary Outcome Measures :
- Incidence of adverse events [ Time Frame: 12 months ]
- Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score [ Time Frame: 12 months ]
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."
The LBP NRS score throughout this protocol is defined as the average of the score of the three questions:
- Low back pain intensity now
- Worst low back pain intensity in the last 14 days
- Average low back pain intensity over the last 14 days
Secondary Outcome Measures :
- Change from baseline in Low Back Pain Numerical Rating Scale (LBP NRS) score [ Time Frame: 3, 6 & 9 months ]
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."
The LBP NRS score throughout this protocol is defined as the average of the score of the three questions:
- Low back pain intensity now
- Worst low back pain intensity in the last 14 days
- Average low back pain intensity over the last 14 days
- Change from baseline in Roland Morris Disability Questionnaire-23 score [ Time Frame: 3, 6, 9 & 12 months ]
- Clinically relevant improvement [ Time Frame: 3, 6, 9 &12 months ]30 percent reduction from baseline in Roland Morris Disability Questionnaire-23 score
- Change from baseline in Oswestry Disability Index [ Time Frame: 3, 6 & 12 months ]
- Plasma pharmacokinetics - Tdur (duration above a prescribed threshold) [ Time Frame: 11 days ]
- Plasma pharmacokinetics - tmax (the time at which Cmax was apparent) [ Time Frame: 11 days ]
- Plasma pharmacokinetics - the area under the concentration versus time curve within a dosing interval [ Time Frame: 11 days ]
- Plasma pharmacokinetics - Cmax (the maximum observed concentration) [ Time Frame: 11 days ]
- Plasma pharmacokinetics - t½ (the apparent terminal half-life) [ Time Frame: 11 days ]
- Plasma pharmacokinetics - CL/F (the systemic clearance calculated from plasma) [ Time Frame: 11 days ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Aged between 18 and 70 years, inclusive.
- Chronic low back pain in the area associated with vertebral body endplate bone oedema (Modic 1) or vertebral body endplate bone oedema and fat (Modic 1 and 2) at a single lumbar level.
- Current episode of chronic low back pain has lasted for ≥ 6 months and < 5 years at the time of randomisation.
- Bodyweight of ≥ 50 kg and ≤ 120 kg.
- Failure of standard of care therapies used by their treating physician
Exclusion Criteria:
- The presence of a deformity associated with the disc
- A clear alternative cause for back pain
- Interventional back procedure in the 6 months prior to screening or major surgery in the 12 weeks prior to screening
- History of alcohol abuse or drugs of abuse in the past 2 years
- Any other significant illness
- Concomitant medications contraindicated with PP353
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238676
Contacts
| Contact: Operations and Project Director | +44 1227 910152 | info@persicapharmaceuticals.com |
Locations
| Belgium | |
| GZA Ziekenhuizen, Campus Sint Augustinus | Recruiting |
| Antwerp, Belgium, 2610 Wilrijk | |
| Contact: Van Gool, MD +32 34433865 Hanna.VanGool@gza.be | |
| New Zealand | |
| CGM Research Trust | Recruiting |
| Christchurch, New Zealand, 8083 | |
| Contact: Nigel Gilchrist, MB ChB FRACP +64 3 3377821 nigel.gilchrist@cdhb.health.nz | |
| Spain | |
| Metge Adjunt. Servei de Medicina Física i Rehabilitació Hospital Universitari Vall d'Hebron | Recruiting |
| Barcelona, Spain, 08035 Barcelona | |
| Contact: Judith Sanchez-Raya, PT, MD, PhD +34 93 489 3494 jusanchez@vhebron.net | |
| Hospital Clinico Universitario | Recruiting |
| Valladolid, Spain, 47003 | |
| Contact: David Cesar Noriega Gonzales Noriega, MD, PhD | |
| United Kingdom | |
| Royal Preston Hospital | Recruiting |
| Preston, Lancashire, United Kingdom, PR2 9HT | |
| Contact: Shiva Tripathi, MBBS MD FRCA +44 1772 524185 Shiva.Tripathi@lthtr.nhs.uk | |
| University Hospital Coventry & Warwickshire | Recruiting |
| Coventry, United Kingdom, CV2 2DX | |
| Contact: Robert Sneath, FRCS 02476965067 robert.sneath@uhcw.nhs.uk | |
Sponsors and Collaborators
Persica Pharmaceuticals Ltd
Micron Research Ltd
Investigators
| Study Chair: | Duncan McHale, MBBS MRCP | Weatherden Ltd |
| Responsible Party: | Persica Pharmaceuticals Ltd |
| ClinicalTrials.gov Identifier: | NCT04238676 |
| Other Study ID Numbers: |
Persica 002 2018-004488-30 ( EudraCT Number ) U1111-1257-2567 ( Registry Identifier: WHO Universal Trial Number ) |
| First Posted: | January 23, 2020 Key Record Dates |
| Last Update Posted: | June 15, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations |