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
Results First Received: April 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Acute Low Back Pain
Interventions: Drug: nicoboxil
Drug: placebo matching nonivamide + nicoboxil
Drug: nonivamide + nicoboxil (Finalgon)
Drug: nonivamide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Patients treated with placebo ointment
Nicoboxil Patients treated with ointments containing 2.5% nicoboxil alone
Nonivamide Patients treated with ointments containing 0.4% nonivamide alone
Nicoboxil/Nonivamide Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide

Participant Flow:   Overall Study
    Placebo     Nicoboxil     Nonivamide     Nicoboxil/Nonivamide  
STARTED     204     201     198     202  
COMPLETED     118     139     152     169  
NOT COMPLETED     86     62     46     33  
Adverse Event                 1                 0                 9                 13  
Lack of Efficacy                 84                 60                 35                 15  
Protocol Violation                 0                 0                 0                 1  
Withdrawal by Subject                 0                 1                 2                 2  
Other reasons than stated above                 1                 1                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients from Treated Set (TS): Patients who were randomised and who used at least 1 dose of study medication.

Reporting Groups
  Description
Placebo Patients treated with placebo ointment
Nicoboxil Patients treated with ointments containing 2.5% nicoboxil alone
Nonivamide Patients treated with ointments containing 0.4% nonivamide alone
Nicoboxil/Nonivamide Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
Total Total of all reporting groups

Baseline Measures
    Placebo     Nicoboxil     Nonivamide     Nicoboxil/Nonivamide     Total  
Number of Participants  
[units: participants]
  204     201     198     202     805  
Age  
[units: years]
Mean ± Standard Deviation
  39.2  ± 13.27     40.4  ± 13.06     42.2  ± 13.53     40.2  ± 14.31     40.5  ± 13.57  
Gender  
[units: participants]
         
Female     94     91     103     100     388  
Male     110     110     95     102     417  



  Outcome Measures
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1.  Primary:   Pain Intensity Difference (PID) Between Pre-dose Baseline and 8hours After First Application   [ Time Frame: Baseline and 8 hours after first ointment application ]

2.  Secondary:   Pain Intensity Difference (PID) Between Pre-dose Baseline and 4 Hours After First Application   [ Time Frame: Baseline and 4 hours after first ointment application ]

3.  Secondary:   Difference Between Baseline Pain Intensity and Average Pain Intensity on the Last Individual Treatment Day   [ Time Frame: Baseline and 1 to 4 days ]

4.  Secondary:   Patient Assessment of Efficacy on the Last Individual Treatment Day   [ Time Frame: 1 to 4 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


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