Evaluation of the Efficacy and Safety of Diclofenac HPBCD 75mg/ml in Treatment of Pain Following Dental Surgery

Conditions

Dental Pain

Brief summary

The present study is aimed at demonstrating the therapeutic equivalence of diclofenac HPBCD 75mg/1ml s.c. with the marketed reference product, Voltarol® 75mg/3ml i.m. in the treatment of acute moderate-to-severe pain after dental impaction surgery.

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Interventions

DRUGDiclofenac HPBCD s.c. 75mg/ml

1 single injection at day of dental surgical extraction

DRUGVoltarol 75mg/3ml i.m.

1 single injection at day of dental surgical extraction

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

* Patients undergoing surgical extraction of a single fully or partially impacted mandibular 3rd molar requiring bone removal. * Patients experiencing moderate to severe post-operative pain within 6 hours from end of surgery. * Pre-operative laboratory tests in the reference ranges or without clinically significant abnormalities as judged by the Investigator.

Exclusion criteria

* Surgery performed under general anaesthesia, or sedation. * Complications occurring during the surgical procedure or in the period before randomisation as judged by the investigator. * Acute local or systemic infection at the time of surgery that could confound the post-surgical evaluation. * Patients with clinical signs of gastritis, gastro-duodenal ulcer, GI bleeding. Other GI disturbances or disease that in the opinion of the investigator could be negatively affected by the administration of NSAIDs. * Clinical signs or history of coagulation disorders that could be negatively affected by NSAIDs administration. * Hepatic or renal impairment. * Patients with significant cardiac impairment, history of cerebrovascular disease, history or peripheral arterial disease, uncontrolled hypertension. * Hypersensitivity to diclofenac or other NSAIDs or to one of the study medication components. * Patients under chronic treatment with topical or systemic analgesics/NSAIDs. * Patients under treatment with any medication that may affect the treatment efficacy evaluation. * Patients under treatment with any medication whose concomitant use may be susceptible to interactions with diclofenac or may affect safety.

Design outcomes

Primary

Measure	Time frame	Description
Pain Intensity Difference (PID)	1.5 hours	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).

Secondary

Measure	Time frame
PIDs	at 15 minutes post-dose.

Countries

United Kingdom

Participant flow

Recruitment details

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.

Participants by arm

Arm	Count
Diclofenac HPBCD s.c. 75mg/ml Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction	70
Voltarol 75mg/3ml i.m. Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction	71
Total	141

Baseline characteristics

Characteristic	Diclofenac HPBCD s.c. 75mg/ml	Voltarol 75mg/3ml i.m.	Total
Age Continuous	28.1 years STANDARD_DEVIATION 6.88	28.7 years STANDARD_DEVIATION 7.08	28.49 years STANDARD_DEVIATION 6.96
Sex: Female, Male Female	42 Participants	32 Participants	74 Participants
Sex: Female, Male Male	28 Participants	39 Participants	67 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	49 / 70	41 / 72
serious Total, serious adverse events	0 / 70	0 / 72

Outcome results

Primary

Pain Intensity Difference (PID)

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).

Time frame: 1.5 hours

Population: 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.

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Diclofenac HPBCD s.c. 75mg/ml	Pain Intensity Difference (PID)	44.8 mm
Voltarol 75mg/3ml i.m.	Pain Intensity Difference (PID)	45.5 mm

Comparison: Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.p-value: 0.81395% CI: [-6.62, 5.2]ANCOVA

Primary

Pain Intensity Difference (PID)

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).

Time frame: 1.5 hours

Population: 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.

Arm	Measure	Value (LEAST_SQUARES_MEAN)
Diclofenac HPBCD s.c. 75mg/ml	Pain Intensity Difference (PID)	44.2 mm
Voltarol 75mg/3ml i.m.	Pain Intensity Difference (PID)	44.7 mm

Comparison: Assuming a difference in means of 0 mm, a common standard deviation of 22.5 mm, a sample size of 60 subjects in each group had 95% power to reject the null hypothesis.p-value: 0.86295% CI: [-6.23, 5.22]ANCOVA

Secondary