Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT00942448
First received: July 17, 2009
Last updated: December 17, 2012
Last verified: February 2011
Results First Received: November 16, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Dental Pain
Interventions: Drug: Diclofenac HPBCD
Other: Placebo s.c.

  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
Patients already scheduled for the surgical extraction of a single fully or partially impacted mandibular 3rd molar underwent a screening visit within 30 days from the scheduled date of surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients under treatment with other analgesics, Major or minor tranquillizers, Muscle relaxant, Antihistamines, MAO inhibitors or corticosteroids had to undergo a wash out period prior to inclusion in the study.

Reporting Groups
  Description
Diclofenac HPBCD s.c. 25mg/ml Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
Diclofenac HPBCD s.c. 50mg/ml Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
Diclofenac HPBCD s.c. 75mg/ml Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
Placebo s.c. (1ml) Placebo s.c. : 1 single injection at day of dental surgical extraction

Participant Flow:   Overall Study
    Diclofenac HPBCD s.c. 25mg/ml     Diclofenac HPBCD s.c. 50mg/ml     Diclofenac HPBCD s.c. 75mg/ml     Placebo s.c. (1ml)  
STARTED     77     76     78     75  
COMPLETED     77     76     78     75  
NOT COMPLETED     0     0     0     0  



  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.
No text entered.

Reporting Groups
  Description
Diclofenac HPBCD s.c. 25mg/ml Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
Diclofenac HPBCD s.c. 50mg/ml Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
Diclofenac HPBCD s.c. 75mg/ml Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
Placebo s.c. (1ml) Placebo s.c. : 1 single injection at day of dental surgical extraction
Total Total of all reporting groups

Baseline Measures
    Diclofenac HPBCD s.c. 25mg/ml     Diclofenac HPBCD s.c. 50mg/ml     Diclofenac HPBCD s.c. 75mg/ml     Placebo s.c. (1ml)     Total  
Number of Participants  
[units: participants]
  77     76     78     75     306  
Age  
[units: years]
Mean ± Standard Deviation
  30.7  ± 10.3     29.5  ± 8.68     30.2  ± 8.76     31.9  ± 11.3     30.56  ± 9.79  
Gender  
[units: participants]
         
Female     46     48     46     44     184  
Male     31     28     32     31     122  



  Outcome Measures
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1.  Primary:   Pain Intensity Difference (PID) on a 0-100 VAS   [ Time Frame: at 1.5 hours after treatment administration ]

2.  Primary:   Pain Intensity Difference (PID) on a 0-100 VAS   [ Time Frame: at 1.5 hours after treatment administration ]

3.  Secondary:   PID   [ Time Frame: at 15 minutes post-dose. ]

4.  Secondary:   PID   [ Time Frame: at 30 minutes post-dose. ]

5.  Secondary:   PID   [ Time Frame: at 45 minutes post-dose. ]

6.  Secondary:   PID   [ Time Frame: at 60 minutes post-dose. ]

7.  Secondary:   PID   [ Time Frame: at 90 minutes post-dose. ]

8.  Secondary:   PID   [ Time Frame: at 2 hours post-dose. ]

9.  Secondary:   PID   [ Time Frame: at 3 hours post-dose. ]

10.  Secondary:   PID   [ Time Frame: at 4 hours post-dose. ]

11.  Secondary:   PID   [ Time Frame: at 5 hours post-dose. ]

12.  Secondary:   PID   [ Time Frame: at 6 hours post-dose. ]

13.  Secondary:   PID   [ Time Frame: at 7 hours post-dose. ]

14.  Secondary:   PID   [ Time Frame: at 8 hours post-dose. ]


  Serious Adverse Events


  Other Adverse Events


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No limitations of the trial have been detected  


Results Point of Contact:  
Name/Title: Barbara Gugliotta
Organization: IBSA Institut Biochimique
phone: +41 58 360 1000
e-mail: barbara.gugliotta@ibsa.ch


No publications provided


Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT00942448     History of Changes
Other Study ID Numbers: 09PUK-DCsc04
Study First Received: July 17, 2009
Results First Received: November 16, 2012
Last Updated: December 17, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products