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Efficacy and Safety of Finalgon® Cream Multiple Doses in Acute Low Back Pain

NCT02300311 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2016-09-13

Study results available
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Summary

To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo in patients with acute low back pain. To investigate the safety and tolerability of repeated use of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).

Conditions

  • Low Back Pain

Interventions

DRUG

nonivamide + nicoboxil (Finalgon cream)

2 cm cream line for a skin area approximately 20 x 20 cm2 up to 3 times in a 24 hour period

DRUG

placebo matching nonivamide + nicoboxil (Finalgon cream)

2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02300311 on ClinicalTrials.gov