Nonivamide/Nicoboxil Ointment in Acute Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01708915
First received: October 16, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The aim of this study is to assess the efficacy and tolerability of Nicoboxil/Nonivamide ointment in comparison to Nicoboxil, Nonivamide, and placebo ointments for the treatment of acute low back pain.


Condition Intervention Phase
Acute Low Back Pain
Drug: nicoboxil
Drug: placebo matching nonivamide + nicoboxil
Drug: nonivamide + nicoboxil (Finalgon)
Drug: nonivamide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multi-centre, Double-blind, Randomised, Parallel Group Study to Assess the Efficacy and Safety of Multiple Doses of Topically Applied Hyperemisation-inducing Ointment (2cm Ointment Line Per Application; up to 3 Times Daily for up to 4 Days) Containing 2.5% Nicoboxil/0.4% Nonivamide Versus 2.5% Nicoboxil, 0.4% Nonivamide and Placebo in Patients 18 to 65 Years of Age With Acute Low Back Pain

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application [ Time Frame: Baseline and 8 hours after first ointment application ] [ Designated as safety issue: No ]
    Pain intensity (PI) was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3, 4, 6 and 8 hours after first ointment application. Means were adjusted for centre effect and baseline value.


Secondary Outcome Measures:
  • Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application [ Time Frame: Baseline and 4 hours after first ointment application ] [ Designated as safety issue: No ]
    Pain intensity was assessed on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible) at pre-dose baseline and 0.5, 1, 2, 3 and 4 hours after first ointment application. Means were adjusted for centre effect and baseline value.

  • Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day [ Time Frame: Baseline and 1 to 4 days ] [ Designated as safety issue: No ]
    Average pain intensity was assessed in the evening of days 1, 2, 3 and 4 on a 11-point numerical rating scale ranging from 0 (no pain) to 10 (worst pain possible). The last individual treatment day is the last day with diary-recorded ointment application. Means were adjusted for centre effect and baseline value.

  • Patient Assessment of Efficacy on the Last Individual Treatment Day [ Time Frame: 1 to 4 days ] [ Designated as safety issue: No ]
    Patient assessment of efficacy was assessed on a 4-point verbal rating scale (VRS, 0 = 'poor', 1 = 'fair', 2 = 'good', 3 = 'very good' relief of the patients' low back pain) in the evening of days 1, 2, 3 and 4. The last individual treatment day is the last day with diary-recorded ointment application


Enrollment: 805
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: nonivamide + nicoboxil (Finalgon)
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Drug: nonivamide + nicoboxil (Finalgon)
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Active Comparator: nonivamide
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Drug: nonivamide
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Active Comparator: nicoboxil
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Drug: nicoboxil
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Placebo Comparator: placebo
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Drug: placebo matching nonivamide + nicoboxil
2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients must sign and date an Informed Consent consistent with International Conference on Hermonisation (ICH)/Good Clinical Practice (GCP) guidelines and local regulation prior to participation in the trial.
  • Patients must agree to cooperate with all trial evaluations and perform all required tasks.
  • Acute low back pain for more than 2 days and less than 21 days (= 3 weeks)
  • Male or female patients aged 18 to 65 years
  • Low back pain rating >5 on a 0-10 numerical rating scale (NRS).
  • Female patients of childbearing potential may participate only in case of availability of a negative urine pregnancy test and a confirmed menstrual period prior to study entry and using a highly effective method of birth control. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1 % per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, appropriate intrauterine devices, sexual abstinence or vasectomised partner. Barrier methods of contraception (e.g. condom, diaphragma or occlusive cap) are accepted if used in combination with spermicides (e.g. foam, gel). Female patients will be considered being of childbearing potential unless surgically sterilised by bilateral tubal ligation/salpingectomy or hysterectomy or post-menopausal for at least one year.

Exclusion criteria:

  • Multilocular pain or panalgesia
  • History of more than three low back pain episodes in the last six months
  • Abnormal findings in at least one of the following assessments: Achilles tendon reflex, patella reflex, heel walking, toe walking, cutaneous sensitivity of the legs (including gluteal region), paresis tests in supine position upon dorsiflexion, plantarflexion, hip flexion, knee extension
  • Bladder and/or rectum dysfunction
  • Acute low back pain due to vertebral collapse or neoplastic, inflammatory (ankylosing spondylitis), traumatic, or infective origins
  • Any condition, disease or concomitant treatment that in the judgement of the Investigator will affect the subject's ability to participate in the clinical trial or which will influence the test methodology used
  • Negative experience in the past with heat treatment for muscle complaints (e. g. hot water bottle, heat pads, hyperemisation-inducing topical creams, ointments or patches)
  • History of treatment of back pain with centrally acting analgesics (e. g. opioids) and muscle relaxants
  • Surgery due to back pain or rehabilitation due to back pain in the last 12 months
  • Spinal injection back pain treatment within 6 months prior to enrollment
  • Intake of antidepressant/antipsychotic medication within 4 weeks prior to enrollment
  • Treatment of the recent low back pain period with oral analgesics for more than 4 consecutive days
  • Locally applied medication to the back within 48 hours prior to enrollment (topical treatments, injections)
  • Administration of other analgesics within 24 h prior to enrollment (exception: acetyl salicylic acid (ASS) up to 100 mg/daily for anti platelet-aggregation therapy)
  • Non-pharmacological low back pain treatment (physiotherapy, heat treatment (e.g. hot water bottle, heat patch, or massages) within 12 h prior to enrollment
  • Participation in an investigational drug or device trial within 4 weeks prior to enrollment
  • Hypersensitivity to Nicoboxil, Nonivamide, or paracetamol
  • Known hypersensitivity to any other ingredient, especially to sorbic acid/sorbate, to citronella oil containing e.g. the fragrance compounds geraniol, citronellol and citronellal, or to relevant flowers containing these compounds such as geranium, lavender, jasmine or rose. For patients with known hypersensitivity to perfumes or known type IV hypersensitivity to fragrance-mix I, the application of the investigational product should be performed only with particular caution.
  • Skin lesions (e. g., rash, dermatitis, bruising, laceration) in the back region
  • Drug dependence and/or alcohol abuse
  • Severe hepatocellular insufficiency
  • Patients who are pregnant or breast-feeding
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01708915

Locations
Germany
69.52.49007 Boehringer Ingelheim Investigational Site
Bad Lippspringe, Germany
69.52.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
69.52.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
69.52.49041 Boehringer Ingelheim Investigational Site
Berlin, Germany
69.52.49033 Boehringer Ingelheim Investigational Site
Berlin, Germany
69.52.49026 Boehringer Ingelheim Investigational Site
Berlin, Germany
69.52.49032 Boehringer Ingelheim Investigational Site
Berlin, Germany
69.52.49002 Boehringer Ingelheim Investigational Site
Einbeck, Germany
69.52.49036 Boehringer Ingelheim Investigational Site
Essen, Germany
69.52.49024 Boehringer Ingelheim Investigational Site
Essen, Germany
69.52.49031 Boehringer Ingelheim Investigational Site
Essen, Germany
69.52.49005 Boehringer Ingelheim Investigational Site
Everswinkel, Germany
69.52.49039 Boehringer Ingelheim Investigational Site
Fürth, Germany
69.52.49018 Boehringer Ingelheim Investigational Site
Goch, Germany
69.52.49025 Boehringer Ingelheim Investigational Site
Großheirath-Rossach, Germany
69.52.49022 Boehringer Ingelheim Investigational Site
Haag, Germany
69.52.49009 Boehringer Ingelheim Investigational Site
Hamburg, Germany
69.52.49019 Boehringer Ingelheim Investigational Site
Hamburg, Germany
69.52.49015 Boehringer Ingelheim Investigational Site
Kaarst, Germany
69.52.49042 Boehringer Ingelheim Investigational Site
Karlsruhe-Rüppurr, Germany
69.52.49040 Boehringer Ingelheim Investigational Site
Köln, Germany
69.52.49035 Boehringer Ingelheim Investigational Site
Köln, Germany
69.52.49027 Boehringer Ingelheim Investigational Site
Köln, Germany
69.52.49013 Boehringer Ingelheim Investigational Site
Köthen, Germany
69.52.49014 Boehringer Ingelheim Investigational Site
Künzing, Germany
69.52.49034 Boehringer Ingelheim Investigational Site
Ludwigshafen, Germany
69.52.49028 Boehringer Ingelheim Investigational Site
Meßkirch, Germany
69.52.49030 Boehringer Ingelheim Investigational Site
Meßkirch, Germany
69.52.49029 Boehringer Ingelheim Investigational Site
Münster, Germany
69.52.49012 Boehringer Ingelheim Investigational Site
Neunkirchen, Germany
69.52.49020 Boehringer Ingelheim Investigational Site
Rodgau, Germany
69.52.49037 Boehringer Ingelheim Investigational Site
Siegen, Germany
69.52.49016 Boehringer Ingelheim Investigational Site
Stockach, Germany
69.52.49010 Boehringer Ingelheim Investigational Site
Straßkirchen, Germany
69.52.49021 Boehringer Ingelheim Investigational Site
Villingen-Schwenningen, Germany
69.52.49023 Boehringer Ingelheim Investigational Site
Wangen, Germany
69.52.49011 Boehringer Ingelheim Investigational Site
Weilburg, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01708915     History of Changes
Other Study ID Numbers: 69.52, 2011-003890-27
Study First Received: October 16, 2012
Results First Received: April 17, 2014
Last Updated: May 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Nonivamide
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014