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Nonivamide/Nicoboxil Ointment in Acute Low Back Pain

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ClinicalTrials.gov Identifier: NCT01708915
Recruitment Status : Completed
First Posted : October 17, 2012
Results First Posted : May 15, 2014
Last Update Posted : May 29, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Tracking Information
First Submitted Date  ICMJE October 16, 2012
First Posted Date  ICMJE October 17, 2012
Results First Submitted Date  ICMJE April 17, 2014
Results First Posted Date  ICMJE May 15, 2014
Last Update Posted Date May 29, 2014
Study Start Date  ICMJE October 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application [ Time Frame: Baseline and 8 hours after first ointment application ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2012)
pain intensity differences (PID) from pre-dose baseline 8hours after first application [ Time Frame: 8 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2014)
  • Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application [ Time Frame: Baseline and 4 hours after first ointment application ]
    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 ]
    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 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2012)
  • pain intensity difference (PID) from pre-dose baseline 4 hours after first application [ Time Frame: 4 hours ]
  • difference of average pain intensity from pre-dose baseline on the last individual treatment day [ Time Frame: 1 - 5 days ]
  • Patient Assessment of Efficacy on the Last Individual Treatment Day [ Time Frame: 1 day ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nonivamide/Nicoboxil Ointment in Acute Low Back Pain
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Acute Low Back Pain
Intervention  ICMJE
  • Drug: nicoboxil
    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
  • 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
  • Drug: nonivamide
    2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
Study Arms  ICMJE
  • 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
    Intervention: Drug: nonivamide + nicoboxil (Finalgon)
  • 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
    Intervention: Drug: nonivamide
  • 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
    Intervention: Drug: nicoboxil
  • 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
    Intervention: Drug: placebo matching nonivamide + nicoboxil
Publications * Gaubitz M, Schiffer T, Holm C, Richter E, Pisternick-Ruf W, Weiser T. Efficacy and safety of nicoboxil/nonivamide ointment for the treatment of acute pain in the low back - A randomized, controlled trial. Eur J Pain. 2016 Feb;20(2):263-73. doi: 10.1002/ejp.719. Epub 2015 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2014)
805
Original Estimated Enrollment  ICMJE
 (submitted: October 16, 2012)
800
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01708915
Other Study ID Numbers  ICMJE 69.52
2011-003890-27 ( EudraCT Number: EudraCT )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boehringer Ingelheim
Study Sponsor  ICMJE Boehringer Ingelheim
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP