Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00942448 |
Recruitment Status
:
Completed
First Posted
: July 21, 2009
Results First Posted
: January 28, 2013
Last Update Posted
: January 28, 2013
|
Sponsor:
IBSA Institut Biochimique SA
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date ICMJE | July 17, 2009 | |||
First Posted Date ICMJE | July 21, 2009 | |||
Results First Submitted Date | November 16, 2012 | |||
Results First Posted Date | January 28, 2013 | |||
Last Update Posted Date | January 28, 2013 | |||
Study Start Date ICMJE | September 2009 | |||
Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Pain Intensity Difference (PID) on a 0-100 VAS [ Time Frame: at 1.5 hours after treatment administration ] Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
|
|||
Original Primary Outcome Measures ICMJE |
Pain Intensity Difference (PID) on a 0-100 VAS [ Time Frame: at 1.5 hours after treatment administration ] | |||
Change History | Complete list of historical versions of study NCT00942448 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
|
|||
Original Secondary Outcome Measures ICMJE |
PID [ Time Frame: at 15, 30, 45 minutes, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours post-dose. ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery | |||
Official Title ICMJE | Efficacy and Safety Study of Diclofenac HPBCD 25, 50 mg/ml Administered as Single s.c. Dose, in the Treatment of Acute Moderate-to-severe Post-surgical Pain From Dental Surgery (Impacted 3rd Molar Extraction) | |||
Brief Summary | The present study is proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute moderate-to-severe pain after dental impaction surgery. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
|||
Condition ICMJE | Dental Pain | |||
Intervention ICMJE |
|
|||
Study Arms |
|
|||
Publications * | Not Provided | |||
* 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 |
306 | |||
Original Estimated Enrollment ICMJE |
300 | |||
Actual Study Completion Date | April 2010 | |||
Actual Primary Completion Date | January 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
|||
Sex/Gender |
|
|||
Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Poland, United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00942448 | |||
Other Study ID Numbers ICMJE | 09PUK-DCsc04 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | IBSA Institut Biochimique SA | |||
Study Sponsor ICMJE | IBSA Institut Biochimique SA | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
|
|||
PRS Account | IBSA Institut Biochimique SA | |||
Verification Date | February 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |