Nucleotides and B Vitamins in the Treatment of Low Back Pain

NCT02640417 | Completed Phase 4

• 1 other identifier: NHCN-03-12-15
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a double-blind, randomized study in parallel groups of subjects presenting with low back pain. Randomized subjects will receive treatment for 60 days with either a combination of nucleotides and vitamin B12 or vitamin B1+B6+B12.

Conditions

Low Back Pain

Keywords

Nucleotides (uridine, cytidine); Vitamin B1; Vitamin B6; Vitamin B12

Outcome Measures

Primary Outcomes (1)

• Adverse Event Occurrence

  Percentage of subjects in each treatment group presenting with adverse events

  Throughout 60 day treatment period

Secondary Outcomes (3)

• Low back pain Questionnaire

  Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)

• Visual Analog Pain Scores

  Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)

• Finger-to-Floor Distance

  Pretreatment, Visit 2 (at 30 days of treatment), Visit 3 (at 60 days of treatment)

Study Arms (2)

Nucleotides + B12

EXPERIMENTAL

Nucleotides + Vitamin B12 Dose: two capsules, three times per day + placebo corresponding to Group B treatment

Drug: Nucleotides + B12

B vitamins

ACTIVE COMPARATOR

Vitamin B1 + Vitamin B6 + Vitamin B12 Dose: one tablet, three times daily + placebo corresponding to Group A treatment

Drug: B Vitamins

Interventions

Nucleotides + B12 DRUG

Oral treatment with either Nucleotides + Vitamin B12

Also known as: Group A

Nucleotides + B12

B Vitamins DRUG

Oral treatment with vitamins B1, B6, and B12

Also known as: Group B

B vitamins

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both genders, at least 18 years of age
• Clinical presentation of acute lumbago (\<3 days of initial visit, with and without functional alteration, with medium intensity: Visual Analog Pain score between 20mm and 80mm
• Female subjects should be post-menopausal or using birth control
• Subjects must sign informed consent document

You may not qualify if:

• Intolerance to any component of the study treatments
• Pregnancy or breastfeeding
• Need for surgical treatment
• Use of other analgesic drugs
• dyshematopoiesis or coagulation disorder
• Gastric or intestinal ulcer
• Gastrointestinal, cerebrovascular, or other bleeding
• Creatinine \>3x% reference range
• Urea, ALT, AST, or GGT \>2x% reference range
• Any other disease or condition that in the investigator's opinion should exclude the subject from the study

Sponsors & Collaborators

• Fundação Educacional Serra dos Órgãos: lead

MeSH Terms

Conditions

Low Back Pain

Interventions

Nucleotides; Vitamin B 12; Vitamin B Complex

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosides; Carbohydrates; Nucleic Acids, Nucleotides, and Nucleosides; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Marco AN Mibielli, MD

  UNIFESO - Fundação Educacional Serra dos Órgãos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman of Orthopedics

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 29, 2015
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: October 1, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04