|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver); Primary Purpose: Treatment |
| Condition: |
Postoperative Pain |
| Interventions: |
Drug: etoricoxib Drug: tramadol |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| All patient recruited and analysed between october 2008 and june 2009 |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Two patients were excluded after randomization forgot study medication and questionnaire leaving the hospital |
| Description | |
|---|---|
| Etoricoxib |
Active study drug: Etoricoxib 90 mg once daily |
| Control Tramadol | Tramadol 100 mg slow release twice daily |
| Etoricoxib | Control Tramadol | |
|---|---|---|
| STARTED | 50 [1] | 50 [1] |
| COMPLETED | 49 [2] | 49 [3] |
| NOT COMPLETED | 1 | 1 |
| Withdrawal by Subject | 1 | 1 |
| [1] | November 2008 |
|---|---|
| [2] | All but one randomsied patient |
| [3] | All but one randomised patient |
Baseline Characteristics
| Description | |
|---|---|
| Etoricoxib |
Active study drug: Etoricoxib 90 mg once daily |
| Control Tramadol | Tramadol 100 mg slow release twice daily |
| Etoricoxib | Control Tramadol | Total | |
|---|---|---|---|
|
Number of Participants
[units: participants] |
50 | 50 | 100 |
|
Age
[units: patients] |
|||
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 50 | 50 | 100 |
| >=65 years | 0 | 0 | 0 |
|
Gender
[units: participants] |
|||
| Female | 50 | 50 | 100 |
| Male | 0 | 0 | 0 |
Outcome Measures
| 1. Primary: | Number of Patients Requiring Rescue Medication [ Time Frame: 7 day study period ] |
| 2. Secondary: | Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain [ Time Frame: The first 7 days after surgery, during study pain medication ] |
| 3. Secondary: | Compliance to Base Medication [ Time Frame: 7-day study period, during study medication ] |
| 4. Secondary: | Gastro-intestinal Symptoms [ Time Frame: during the 7- day pain medication period ] |
| 5. Secondary: | Dizziness/Sleepiness [ Time Frame: During the 7-day pain medication period ] |
| 6. Secondary: | Wound Healing [ Time Frame: 16 week follow-up ] |
| 7. Secondary: | Satisfaction With Pain Medication [ Time Frame: during the first 20 days after surgery, 1st outpatient clinic visit ] |
| 8. Secondary: | Patient Assessed Overall Satisfaction With Surgery/Outcome [ Time Frame: 16 weeks ] |
| 9. Secondary: | Patient Assessed Quality of Life [ Time Frame: At 16-week post surgery follow-up ] |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
| 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 text entered. |
| Responsible Party: | Jan Jakobsson, Foot & Ancle Surgical Center |
| ClinicalTrials.gov Identifier: | NCT00733421 History of Changes |
| Other Study ID Numbers: | 2008HV001, EudraCT number 2008-000791-24 |
| Study First Received: | August 12, 2008 |
| Results First Received: | December 7, 2009 |
| Last Updated: | January 15, 2010 |
| Health Authority: | Sweden: Medical Products Agency |
