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

NCT00942448 | Completed Phase 3 Results

• 1 other identifier: 09PUK-DCsc04
• Study Type: interventional
• Target: 306
• Locations: 2 countries
• Sites: 6

Brief Summary

The present study is proposed to evaluate the efficacy and safety of single doses of Diclofenac HPBCD subcutaneous (s.c.) (25 mg/1 ml and 50 mg/1 ml) in the treatment of acute moderate-to-severe pain after dental impaction surgery.

Conditions

Dental Pain

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Difference (PID) on a 0-100 VAS

  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).

  at 1.5 hours after treatment administration

Secondary Outcomes (12)

• PID

  at 15 minutes post-dose.

• PID

  at 30 minutes post-dose.

• PID

  at 45 minutes post-dose.

• PID

  at 60 minutes post-dose.

• PID

  at 90 minutes post-dose.

Study Arms (4)

Diclofenac HPBCD s.c. 25mg/ml

EXPERIMENTAL

Drug: Diclofenac HPBCD

Diclofenac HPBCD s.c. 50mg/ml

EXPERIMENTAL

Drug: Diclofenac HPBCD

Diclofenac HPBCD s.c. 75mg/ml

ACTIVE COMPARATOR

Drug: Diclofenac HPBCD

Placebo s.c. (1ml)

PLACEBO COMPARATOR

Other: Placebo s.c.

Interventions

Diclofenac HPBCD DRUG

1 single injection at day of dental surgical extraction

Diclofenac HPBCD s.c. 25mg/ml

Placebo s.c. OTHER

1 single injection at day of dental surgical extraction

Placebo s.c. (1ml)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IBSA Institut Biochimique SA: lead

Study Sites (6)

Gabinet Stomatologiczny Bartek

Kobyłka, 05-230, Poland

Location

Centrum Leczenia Chorób Cywilizacyjnych

Warsaw, 02-797, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej

Warsaw, 03-252, Poland

Location

NZOZ Polimedica

Zgierz, 95-100, Poland

Location

The School of Dentistry; University of Birmingham

Birmingham, B4 6NN, United Kingdom

Location

Eastman Dental Institute, University College London

London, WC1X8LD, United Kingdom

Location

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No limitations of the trial have been detected

Results Point of Contact

• Title: Barbara Gugliotta
• Organization: IBSA Institut Biochimique

barbara.gugliotta@ibsa.ch

+41 58 360 1000

Study Officials

• Thomas Dietrich, Prof

  The school of dentistry, University of Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 21, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2010
• Last Updated: January 28, 2013
• Results First Posted: January 28, 2013

Record last verified: 2011-02

Locations

GB (2); PL (4)