NCT01708915

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
805

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

May 15, 2014

Completed
Last Updated

May 29, 2014

Status Verified

May 1, 2014

Enrollment Period

6 months

First QC Date

October 16, 2012

Results QC Date

April 17, 2014

Last Update Submit

May 20, 2014

Conditions

Acute Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First 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.

    Baseline and 8 hours after first ointment application

Secondary Outcomes (3)

  • Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application

    Baseline and 4 hours after first ointment application

  • Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day

    Baseline and 1 to 4 days

  • Patient Assessment of Efficacy on the Last Individual Treatment Day

    1 to 4 days

Study Arms (4)

nonivamide + nicoboxil (Finalgon)

ACTIVE COMPARATOR

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)

nonivamide

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Drug: nicoboxil

placebo

PLACEBO COMPARATOR

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

Interventions

nicoboxilDRUG

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

nicoboxil
placebo matching nonivamide + nicoboxilDRUG

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

placebo
nonivamide + nicoboxil (Finalgon)DRUG

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

nonivamide + nicoboxil (Finalgon)
nonivamideDRUG

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

nonivamide

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

69.52.49007 Boehringer Ingelheim Investigational Site

Bad Lippspringe, Germany

Location

69.52.49003 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

69.52.49004 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

69.52.49026 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

69.52.49032 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

69.52.49033 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

69.52.49041 Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

69.52.49027 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

69.52.49035 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

69.52.49040 Boehringer Ingelheim Investigational Site

Cologne, Germany

Location

69.52.49002 Boehringer Ingelheim Investigational Site

Einbeck, Germany

Location

69.52.49024 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

69.52.49031 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

69.52.49036 Boehringer Ingelheim Investigational Site

Essen, Germany

Location

69.52.49005 Boehringer Ingelheim Investigational Site

Everswinkel, Germany

Location

69.52.49039 Boehringer Ingelheim Investigational Site

Fürth, Germany

Location

69.52.49018 Boehringer Ingelheim Investigational Site

Goch, Germany

Location

69.52.49025 Boehringer Ingelheim Investigational Site

Großheirath-Rossach, Germany

Location

69.52.49022 Boehringer Ingelheim Investigational Site

Haag, Germany

Location

69.52.49009 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

69.52.49019 Boehringer Ingelheim Investigational Site

Hamburg, Germany

Location

69.52.49015 Boehringer Ingelheim Investigational Site

Kaarst, Germany

Location

69.52.49042 Boehringer Ingelheim Investigational Site

Karlsruhe-Rüppurr, Germany

Location

69.52.49013 Boehringer Ingelheim Investigational Site

Köthen, Germany

Location

69.52.49014 Boehringer Ingelheim Investigational Site

Künzing, Germany

Location

69.52.49034 Boehringer Ingelheim Investigational Site

Ludwigshafen, Germany

Location

69.52.49028 Boehringer Ingelheim Investigational Site

Messkirch, Germany

Location

69.52.49030 Boehringer Ingelheim Investigational Site

Messkirch, Germany

Location

69.52.49029 Boehringer Ingelheim Investigational Site

Münster, Germany

Location

69.52.49012 Boehringer Ingelheim Investigational Site

Neunkirchen, Germany

Location

69.52.49020 Boehringer Ingelheim Investigational Site

Rodgau, Germany

Location

69.52.49037 Boehringer Ingelheim Investigational Site

Siegen, Germany

Location

69.52.49016 Boehringer Ingelheim Investigational Site

Stockach, Germany

Location

69.52.49010 Boehringer Ingelheim Investigational Site

Straßkirchen, Germany

Location

69.52.49021 Boehringer Ingelheim Investigational Site

Villingen-Schwenningen, Germany

Location

69.52.49023 Boehringer Ingelheim Investigational Site

Wangen, Germany

Location

69.52.49011 Boehringer Ingelheim Investigational Site

Weilburg, Germany

Location

Related Publications (1)

  • 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.

    PMID: 25929250DERIVED

MeSH Terms

Interventions

nicoboxilnonivamide

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2012

First Posted

October 17, 2012

Study Start

October 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

May 29, 2014

Results First Posted

May 15, 2014

Record last verified: 2014-05

Locations

DE(37)