Health Condition 1: null- lower back pain (L5 -S1)
Conditions
Interventions
Intervention1: Dexpanthenol: Pantothenic acid and its derivatives, 4â??-phosphopantothenic acid, pantothenol and pantethine, have been shown in vitro to protect cells against lipid peroxidation.
Inter
Sponsors
Rusan Pharma Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria To participate in this study, subjects must meet all of the following criteria. Screening: 1. Given written informed consent prior to study participation. 2. Agreed to stop taking pain medication from day -7 until day 14 of the study (rescue medication of 650 mg paracetamol allowed if required) 3. Persistent lower back pain (L5-S1) for a minimum of 3 months i.e. very tender low lumbar localised spot just above the pelvic crest (about 3-5 cm) and lateral to the vertebral spine (2-4 cm left or right of the midline, level with the L5-S1 facet joint). 4. Male or female subject aged 18 years or over. 5. Vital signs within the following ranges: • Pulse rate 40-90 bpm • Systolic blood pressure 90-140 mmHg • Diastolic blood pressure 50-90 mmHg. 6. Ability to communicate well with the Investigator and to comply with the requirements of the study. Dosing Day (pre-dose): 1. Minimum total pain severity score of 28 over the 7 days immediately prior to dosing
Exclusion criteria
Exclusion criteria: At screening: 1. Presence of any clinically significant medical condition as determined by the Investigator (including active or chronic infection, bacterial, viral, parasitic or worm infections, HIV-1, HIV-2 or Hepatitis B and C) 2. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug (e.g. renal or liver disease, respiratory, immunological, endocrine or neurological disorders) 3. Present or history of referred pain 4. Slipped disc and/or neurological signs in lower limbs past as well as present 5. Rheumatoid arthritis and systemic arthritic disease 6. Morbid obesity (BMI of 40 Kg/m2 or over) 7. Degenerative autoimmune diseases, neurological disease, tumours, kidney diseases and uterine problems 8. Pregnant or lactating female patients and those not using contraceptives.. 9. Any ECG abnormality other than sinus bradycardia or respiratory sinus arrhythmia 10. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the investigational medicinal products 11. Use of any oral or injected steroids, current or taken within 30 days of screening or during the study (inhaled steroids for asthma are acceptable although dose should remain constant throughout the study if possible) 12. Use of warfarin, heparin or other anticoagulants within 30 days of screening or during the study 13. Use of anti arrhythmic drugs class III (e.g. amiodarone) within 30 days of screening or during the study 14. Use of medication for pain relief from day -7 to follow-up (day 14) apart from rescue medication (650 mg paracetamol). 15. Any skin disorder, broken skin, scars or tattoos at the proposed injection site 16. History or evidence of drug abuse 17. Participation in another clinical study within the last three months. Dosing Day (pre-dose): 1. Development of any exclusion criteria since last visit 2. Use of any excluded medication since last visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of a single peri-articular 5 ml PBF 001 injection compared to a single peri-articular 5 ml placebo injection in male and female subjects with non-specific lower back pain (L5-S1).â?¢ Back tenderness scores Medical history and physical examination Laboratory safety tests(Haematology,Biochemistry,Urinalysis) Pregnancy tests Virology screening Vital signs ECGs Timepoint: baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14). | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To determine the effect on pain of a single peri-articular 5 ml PBF 001 injection compared to a single peri-articular 5 ml placebo injection in male and female subjects with non-specific lower back pain (L5-S1) â?¢ To assess the effects on patient mobility of a single peri-articular 5 ml PBF 001 injection compared to a single peri-articular 5 ml placebo injection in male and female subjects with non-specific lower back pain (L5-S1). Pain severity scores Mobility and activity scores Timepoint: baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14). | — |
Countries
India
Contacts
Public ContactDr Dhruv Bibra
Indian Spinal Injuries Centre
Outcome results
None listed