Trial Outcomes & Findings for The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery (NCT NCT00733421)

Results Overview

Number of patients requiring any further pain medication

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

100 participants

Primary outcome timeframe

7 day study period

Results posted on

2010-01-20

Participant Flow

All patient recruited and analysed between october 2008 and june 2009

Two patients were excluded after randomization forgot study medication and questionnaire leaving the hospital

Participant milestones

Participant milestones
Measure	Etoricoxib Active study drug: Etoricoxib 90 mg once daily	Control Tramadol Tramadol 100 mg slow release twice daily
Overall Study STARTED	50	50
Overall Study COMPLETED	49	49
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Etoricoxib Active study drug: Etoricoxib 90 mg once daily	Control Tramadol Tramadol 100 mg slow release twice daily
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

The Effect of Anti-inflammatory Analgesics on Pain Following Hallux Valgus Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Etoricoxib n=50 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=50 Participants Tramadol 100 mg slow release twice daily	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants	50 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 7 day study period

Number of patients requiring any further pain medication

Outcome measures

Outcome measures
Measure	Etoricoxib n=49 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=49 Participants Tramadol 100 mg slow release twice daily
Number of Patients Requiring Rescue Medication	29 patients	36 patients

SECONDARY outcome

Timeframe: The first 7 days after surgery, during study pain medication

VAS score 1-10 1=no pain 10 = worst possible pain, summary variable day 1-7; 7 - 70

Outcome measures

Outcome measures
Measure	Etoricoxib n=49 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=49 Participants Tramadol 100 mg slow release twice daily
Summary of Pain Scores, Day 1-7 of Visual Analogue Scale Grading of Pain	12 scores on a scale Standard Deviation 8	17 scores on a scale Standard Deviation 11

SECONDARY outcome

Timeframe: 7-day study period, during study medication

Number of patients that did not discontinue study medication before day 7

Outcome measures

Outcome measures
Measure	Etoricoxib n=49 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=49 Participants Tramadol 100 mg slow release twice daily
Compliance to Base Medication	49 patients	43 patients

SECONDARY outcome

Timeframe: during the 7- day pain medication period

Number of patients reporting any gastro-intestinal side effects; nausea and or vomiting, gastritis etc. assessed by patient and documented in written questionnaire

Outcome measures

Outcome measures
Measure	Etoricoxib n=49 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=49 Participants Tramadol 100 mg slow release twice daily
Gastro-intestinal Symptoms	6 patients	20 patients

SECONDARY outcome

Timeframe: During the 7-day pain medication period

Number of patients that experienced dizziness/sleepiness/fatigue, assessed by patient and documented in written questionnaire

Outcome measures

Outcome measures
Measure	Etoricoxib n=49 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=49 Participants Tramadol 100 mg slow release twice daily
Dizziness/Sleepiness	2 patients	13 patients

SECONDARY outcome

Timeframe: 16 week follow-up

healing process assessed by a blinded physician during the final outpatient clinic visit assessment graded; Good/neutral/bad

Outcome measures

Outcome measures
Measure	Etoricoxib n=42 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=47 Participants Tramadol 100 mg slow release twice daily
Wound Healing Goood	37 patients	39 patients
Wound Healing Neutral	5 patients	6 patients
Wound Healing Bad	0 patients	2 patients

SECONDARY outcome

Timeframe: during the first 20 days after surgery, 1st outpatient clinic visit

satisfied or unsatisfied with study medication, assessed by patient in questionnaire

Outcome measures

Outcome measures
Measure	Etoricoxib n=49 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=49 Participants Tramadol 100 mg slow release twice daily
Satisfaction With Pain Medication Satisfied	47 patients	39 patients
Satisfaction With Pain Medication Not satisfied	2 patients	10 patients

SECONDARY outcome

Timeframe: 16 weeks

overall satisfaction with outcome, patients assessed satisfaction with the surgical procedure; satisfied, neutral or unsatisfied, written questionnaire.

Outcome measures

Outcome measures
Measure	Etoricoxib n=49 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=49 Participants Tramadol 100 mg slow release twice daily
Patient Assessed Overall Satisfaction With Surgery/Outcome satisfied	45 Patients.	44 Patients.
Patient Assessed Overall Satisfaction With Surgery/Outcome neutral	4 Patients.	4 Patients.
Patient Assessed Overall Satisfaction With Surgery/Outcome unsatisfied	0 Patients.	1 Patients.

SECONDARY outcome

Timeframe: At 16-week post surgery follow-up

Quality of Life evaluated by grading on a Visual Analogue Scale in the written questionnaireisual analogue scale grading 0-100; 0 death and 100 perfect quality of life

Outcome measures

Outcome measures
Measure	Etoricoxib n=48 Participants Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=49 Participants Tramadol 100 mg slow release twice daily
Patient Assessed Quality of Life	94.5 score on a scale Standard Deviation 9.4	94.7 score on a scale Standard Deviation 7.8

Adverse Events

Etoricoxib

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Control Tramadol

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Etoricoxib n=49 participants at risk Active study drug: Etoricoxib 90 mg once daily	Control Tramadol n=49 participants at risk Tramadol 100 mg slow release twice daily
Gastrointestinal disorders Nausea	12.2% 6/49 • Number of events 6	40.8% 20/49 • Number of events 20
Nervous system disorders dizziness	4.1% 2/49 • Number of events 2	30.6% 15/49 • Number of events 15

Additional Information

Jan Jakobsson PI, MD, PhD, Professor

Foot & Ankle Surgical Centre

Phone: 46702500960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place