Trial Outcomes & Findings for Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery (NCT NCT00942448)

NCT ID: NCT00942448

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 assigned by the patient on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 306 participants
• Primary outcome timeframe: at 1.5 hours after treatment administration
• Results posted on: 2013-01-28

Participant Flow

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.

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.

Participant milestones

Measure	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
Overall Study STARTED	77	76	78	75
Overall Study COMPLETED	77	76	78	75
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction	Total n=306 Participants Total of all reporting groups
Age Continuous	30.7 years STANDARD_DEVIATION 10.3 • n=5 Participants	29.5 years STANDARD_DEVIATION 8.68 • n=7 Participants	30.2 years STANDARD_DEVIATION 8.76 • n=5 Participants	31.9 years STANDARD_DEVIATION 11.3 • n=4 Participants	30.56 years STANDARD_DEVIATION 9.79 • n=21 Participants
Sex: Female, Male Female	46 Participants n=5 Participants	48 Participants n=7 Participants	46 Participants n=5 Participants	44 Participants n=4 Participants	184 Participants n=21 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	28 Participants n=7 Participants	32 Participants n=5 Participants	31 Participants n=4 Participants	122 Participants n=21 Participants

PRIMARY outcome

Timeframe: at 1.5 hours after treatment administration

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
Pain Intensity Difference (PID) on a 0-100 VAS	36.5 mm Interval 31.7 to 41.2	37.3 mm Interval 32.6 to 42.1	37.7 mm Interval 33.0 to 42.4	12.3 mm Interval 7.44 to 17.1

PRIMARY outcome

Timeframe: at 1.5 hours after treatment administration

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
Pain Intensity Difference (PID) on a 0-100 VAS	36.5 mm Interval 31.7 to 41.2	37.3 mm Interval 32.6 to 42.1	37.7 mm Interval 33.0 to 42.4	12.3 mm Interval 7.44 to 17.1

SECONDARY outcome

Timeframe: at 15 minutes post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	8.39 mm Standard Deviation 14.1	8.28 mm Standard Deviation 13.7	9.46 mm Standard Deviation 15.7	1.59 mm Standard Deviation 11.3

SECONDARY outcome

Timeframe: at 30 minutes post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	15.9 mm Standard Deviation 16.4	18.5 mm Standard Deviation 19.5	18.6 mm Standard Deviation 18.9	4.68 mm Standard Deviation 17.2

SECONDARY outcome

Timeframe: at 45 minutes post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	24.7 mm Standard Deviation 17.9	27.5 mm Standard Deviation 22.1	27.8 mm Standard Deviation 19.0	9.00 mm Standard Deviation 20.9

SECONDARY outcome

Timeframe: at 60 minutes post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	30.7 mm Standard Deviation 18.0	34.6 mm Standard Deviation 23.0	34.6 mm Standard Deviation 18.7	15.3 mm Standard Deviation 24.0

SECONDARY outcome

Timeframe: at 90 minutes post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	36.2 mm Standard Deviation 19.2	40.1 mm Standard Deviation 20.8	39.0 mm Standard Deviation 18.9	18.0 mm Standard Deviation 26.0

SECONDARY outcome

Timeframe: at 2 hours post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	38.8 mm Standard Deviation 19.1	43.9 mm Standard Deviation 20.4	42.5 mm Standard Deviation 18.2	26.5 mm Standard Deviation 25.1

SECONDARY outcome

Timeframe: at 3 hours post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	41.2 mm Standard Deviation 20.0	45.5 mm Standard Deviation 21.0	45.6 mm Standard Deviation 19.2	25.3 mm Standard Deviation 26.8

SECONDARY outcome

Timeframe: at 4 hours post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	38.1 mm Standard Deviation 21.2	46.3 mm Standard Deviation 21.8	48.0 mm Standard Deviation 18.6	29.1 mm Standard Deviation 26.8

SECONDARY outcome

Timeframe: at 5 hours post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	37.5 mm Standard Deviation 20.9	42.2 mm Standard Deviation 23.8	45.6 mm Standard Deviation 18.3	31.8 mm Standard Deviation 22.0

SECONDARY outcome

Timeframe: at 6 hours post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	41.5 mm Standard Deviation 19.8	40.9 mm Standard Deviation 23.4	41.7 mm Standard Deviation 22.4	36.5 mm Standard Deviation 14.6

SECONDARY outcome

Timeframe: at 7 hours post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	43.2 mm Standard Deviation 17.9	41.6 mm Standard Deviation 24.3	43.0 mm Standard Deviation 19.2	39.1 mm Standard Deviation 13.5

SECONDARY outcome

Timeframe: at 8 hours post-dose.

Population: The reported number of analized participants were included in the ITT which was defined as 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);

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).

Outcome measures

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 Participants Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 Participants Placebo s.c. : 1 single injection at day of dental surgical extraction
PID	45.0 mm Standard Deviation 15.7	43.8 mm Standard Deviation 25.2	43.6 mm Standard Deviation 17.5	37.0 mm Standard Deviation 14.3

Adverse Events

Diclofenac HPBCD s.c. 25mg/ml

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Diclofenac HPBCD s.c. 50mg/ml

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Diclofenac HPBCD s.c. 75mg/ml

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo s.c. (1ml)

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 participants at risk Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 participants at risk Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 participants at risk Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 participants at risk Placebo s.c. : 1 single injection at day of dental surgical extraction
Infections and infestations gingival abscess	0.00% 0/77	1.3% 1/76 • Number of events 76	0.00% 0/78	0.00% 0/75

Other adverse events

Measure	Diclofenac HPBCD s.c. 25mg/ml n=77 participants at risk Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 50mg/ml n=76 participants at risk Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Diclofenac HPBCD s.c. 75mg/ml n=78 participants at risk Diclofenac HPBCD : 1 single injection at day of dental surgical extraction	Placebo s.c. (1ml) n=75 participants at risk Placebo s.c. : 1 single injection at day of dental surgical extraction
Nervous system disorders Headache	3.9% 3/77 • Number of events 5	3.9% 3/76 • Number of events 3	6.4% 5/78 • Number of events 6	6.7% 5/75 • Number of events 6

Additional Information

Barbara Gugliotta

IBSA Institut Biochimique

Phone: +41 58 360 1000

Email: barbara.gugliotta@ibsa.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60