Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery (NCT NCT00943098)
NCT ID: NCT00943098
Last Updated: 2013-01-28
Results Overview
Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
COMPLETED
PHASE3
142 participants
1.5 hours
2013-01-28
Participant Flow
Patients already scheduled for the surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal underwent a screening visit within 30 days from the scheduled date of surgery.
Participant milestones
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
72
|
|
Overall Study
COMPLETED
|
70
|
72
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery
Baseline characteristics by cohort
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
28.1 years
STANDARD_DEVIATION 6.88 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 7.08 • n=7 Participants
|
28.49 years
STANDARD_DEVIATION 6.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1.5 hoursPopulation: Analysed patients are those included in the PP population: all patients included in the ITT population who also met all inclusion/exclusion criteria and who did not have any major protocol violation, and with post-surgical pain assessment at the primary endpoint.
Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=64 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=65 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
Pain Intensity Difference (PID)
|
44.8 mm
95% Confidence Interval 40.5 to 49.1 • Interval 40.5 to 49.1
|
45.5 mm
Interval 41.2 to 49.8
|
PRIMARY outcome
Timeframe: 1.5 hoursPopulation: Analysed patients are those included in the ITT population: defined as all randomised patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose.
Pain intensity difference (PID) was derived by subtracting each pain intensity score (PI) from the baseline PI score (t0), where PI was assessed by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
Pain Intensity Difference (PID)
|
44.2 mm
Interval 40.0 to 48.3
|
44.7 mm
Interval 40.6 to 48.8
|
SECONDARY outcome
Timeframe: at 15 minutes post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
7.37 mm
Standard Deviation 13.1
|
6.83 mm
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: at 30 minutes post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
19.8 mm
Standard Deviation 17.1
|
18.4 mm
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: at 45 minutes post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
31.2 mm
Standard Deviation 18.8
|
37.9 mm
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: at 60 minutes post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
37.6 mm
Standard Deviation 18.8
|
37.9 mm
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: at 90 minutes post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
44.0 mm
Standard Deviation 18.4
|
45.0 mm
Standard Deviation 17.9
|
SECONDARY outcome
Timeframe: at 2 hours post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
49.0 mm
Standard Deviation 16.0
|
50.3 mm
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: at 3 hours post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
49.7 mm
Standard Deviation 17.0
|
53.3 mm
Standard Deviation 15.0
|
SECONDARY outcome
Timeframe: at 4 hours post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
50.6 mm
Standard Deviation 14.6
|
53.9 mm
Standard Deviation 15.5
|
SECONDARY outcome
Timeframe: at 5 hours post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
48.7 mm
Standard Deviation 15.7
|
52.3 mm
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: at 6 hours post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
47.5 mm
Standard Deviation 14.4
|
51.2 mm
Standard Deviation 16.3
|
SECONDARY outcome
Timeframe: at 7 hours post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
42.8 mm
Standard Deviation 17.2
|
49.6 mm
Standard Deviation 18.2
|
SECONDARY outcome
Timeframe: at 8 hours post-dose.Population: Analysed patients were included in the ITT population: all randomized patients who received the study medication and with at least one post-baseline efficacy evaluation within 1.5 hours post-dose (primary endpoint).
Outcome measures
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 Participants
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=71 Participants
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
PIDs
|
43.7 mm
Standard Deviation 15.8
|
47.1 mm
Standard Deviation 17.9
|
Adverse Events
Diclofenac HPBCD s.c. 75mg/ml
Voltarol 75mg/3ml i.m.
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Diclofenac HPBCD s.c. 75mg/ml
n=70 participants at risk
Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
|
Voltarol 75mg/3ml i.m.
n=72 participants at risk
Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
18.6%
13/70 • Number of events 14 • Adverse events were reported from the signature o fthe informed consent to study end.
|
4.2%
3/72 • Number of events 3 • Adverse events were reported from the signature o fthe informed consent to study end.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
5/70 • Number of events 5 • Adverse events were reported from the signature o fthe informed consent to study end.
|
0.00%
0/72 • Adverse events were reported from the signature o fthe informed consent to study end.
|
|
General disorders
injection site haematoma
|
17.1%
12/70 • Number of events 12 • Adverse events were reported from the signature o fthe informed consent to study end.
|
5.6%
4/72 • Number of events 4 • Adverse events were reported from the signature o fthe informed consent to study end.
|
|
General disorders
Injection site pain
|
15.7%
11/70 • Number of events 11 • Adverse events were reported from the signature o fthe informed consent to study end.
|
11.1%
8/72 • Number of events 8 • Adverse events were reported from the signature o fthe informed consent to study end.
|
|
General disorders
Injection site reaction
|
10.0%
7/70 • Number of events 7 • Adverse events were reported from the signature o fthe informed consent to study end.
|
11.1%
8/72 • Number of events 8 • Adverse events were reported from the signature o fthe informed consent to study end.
|
|
Infections and infestations
Alveolar osteitis
|
8.6%
6/70 • Number of events 7 • Adverse events were reported from the signature o fthe informed consent to study end.
|
5.6%
4/72 • Number of events 4 • Adverse events were reported from the signature o fthe informed consent to study end.
|
|
Infections and infestations
Nasopharyngitis
|
2.9%
2/70 • Number of events 2 • Adverse events were reported from the signature o fthe informed consent to study end.
|
5.6%
4/72 • Number of events 4 • Adverse events were reported from the signature o fthe informed consent to study end.
|
|
Infections and infestations
wound infection
|
4.3%
3/70 • Number of events 3 • Adverse events were reported from the signature o fthe informed consent to study end.
|
6.9%
5/72 • Number of events 5 • Adverse events were reported from the signature o fthe informed consent to study end.
|
|
Nervous system disorders
Headache
|
15.7%
11/70 • Number of events 12 • Adverse events were reported from the signature o fthe informed consent to study end.
|
9.7%
7/72 • Number of events 7 • Adverse events were reported from the signature o fthe informed consent to study end.
|
Additional Information
Barbara Gugliotta, Clincial Research Manager
IBSA Institut Biochimique
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60