A clinical trial to study the safety and efficacy of PBF-001 injection in male and female subjects complaining of non specific lower back pain.

Phase 2

Completed

Conditions: lower back pain (L5 -S1)

Registration Number: CTRI/2015/04/005686

Lead Sponsor: Rusan Pharma Ltd

Brief Summary: Patients suffering from nonspecific lower back pain often fail to respond to existing treatment options and persistence of pain can affect their quality of life. Many resort to surgery which does not always resolve the pain. In this case the pain suffered by these patients is often considered to a psychological issue. Dr. Sherwood has considerable clinical experience using pantothenic acid to treat lower back pain and has found it to be of great value in reducing pain and inflammation when injected intraarticularly or periarticularly into the facet region of painful or inflamed joint. Till date Dr. Sherwoodâ€™s findings have not been explored in a controlled clinical study. In this study we intend to evaluate the safety, efficacy and tolerability of Dexpanthenol injection in patients suffering from lower back pain .

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

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: â€¢Pulse rate 40-90 bpm â€¢Systolic blood pressure 90-140 mmHg â€¢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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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€¢	baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14).
Back tenderness scores	baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14).
Medical history and physical examination	baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14).
Laboratory safety tests(Haematology,Biochemistry,Urinalysis)	baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14).
Pregnancy tests	baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14).
Virology screening	baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14).
Vital signs	baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14).
ECGs	baseline, 2 hours, 24 hrs (day 1) post injection, day 7 and at follow-up (day 14).

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1): Delhi pain management center
🇮🇳
Delhi, DELHI, India
Delhi pain management center
🇮🇳Delhi, DELHI, India
Dr Dhruv Bibra
Principal investigator
9999459608
dbibra@gmail.com