Dental PainPhase 3NCT00943098

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

A Phase 3 study testing Diclofenac HPBCD s.c. 75mg/ml and Voltarol 75mg/3ml i.m. in people with Dental Pain, run by IBSA Institut Biochimique SA at 3 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Dental Pain
What is being tested?: Diclofenac HPBCD s.c. 75mg/ml and Voltarol 75mg/3ml i.m.
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 3 sitesUnited Kingdom
Study dates: Sep 2009to May 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 11Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United Kingdom3 sites

The School of Dentistry, University of Birmingham
Birmingham
Department of oral Surgery; University Dental Hospital
Cardiff
The School of Clinical Dentistry, The University of Sheffield
Sheffield

Other trials in United Kingdom

About this study

Official title: Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg/1ml Injection as Compared to a Single i.m. Voltarol® 75mg/3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).

Conditions: Dental Pain
Being tested: Diclofenac HPBCD s.c. 75mg/ml, Voltarol 75mg/3ml i.m.
Medical subject headings: Toothache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Diclofenac HPBCD s.c. 75mg/mlDrug
1 single injection at day of dental surgical extraction
Voltarol 75mg/3ml i.m.Drug
1 single injection at day of dental surgical extraction

Study groups in NCT00943098
Study group	Role	What they receive
Diclofenac HPBCD s.c. 75mg/ml	Experimental	Not described Receives: Drug: Diclofenac HPBCD s.c. 75mg/ml
Voltarol 75mg/3ml i.m.	Active comparator	Not described Receives: Drug: Voltarol 75mg/3ml i.m.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 1.5 hours

Secondary outcomes (12)

PIDs
Measured: at 15 minutes post-dose.
PIDs
Measured: at 30 minutes post-dose.
PIDs
Measured: at 45 minutes post-dose.
PIDs
Measured: at 60 minutes post-dose.
PIDs
Measured: at 90 minutes post-dose.
PIDs
Measured: at 2 hours post-dose.
PIDs
Measured: at 3 hours post-dose.
PIDs
Measured: at 4 hours post-dose.
PIDs
Measured: at 5 hours post-dose.
PIDs
Measured: at 6 hours post-dose.
PIDs
Measured: at 7 hours post-dose.
PIDs
Measured: at 8 hours post-dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2009May 2010

First posted22 Jul 2009 (estimated)
Study startSep 2009
Primary completionMar 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00943098
Sponsor's protocol ID: 09PUK-DCsc05
Status last verified: Dec 2012
First submitted: 21 Jul 2009
Last updated: 28 Jan 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dental Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of a Single s.c. Diclofenac HPBCD 75mg/1ml Injection as Compared to a Single i.m. Voltarol® 75mg/3ml, in the Treatment of Acute Moderate-to-severe Post-surgical Pain Following Dental Surgery (Impacted 3rd Molar Removal).
ClinicalTrials.gov ID: NCT00943098
Acronym / sponsor ID: 09PUK-DCsc05
Conditions: Dental Pain
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: Mar 2010 (actual)
Study completion: May 2010 (actual)
First posted: 22 Jul 2009 (estimated)
Results: Posted 28 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Diclofenac HPBCD s.c. 75mg/ml	Experimental	Drug: Diclofenac HPBCD s.c. 75mg/ml
Voltarol 75mg/3ml i.m.	Active comparator	Drug: Voltarol 75mg/3ml i.m.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Diclofenac HPBCD s.c. 75mg/ml1 single injection at day of dental surgical extraction	Drug	Diclofenac HPBCD s.c. 75mg/ml
Voltarol 75mg/3ml i.m.1 single injection at day of dental surgical extraction	Drug	Voltarol 75mg/3ml i.m.

Primary outcome

Pain Intensity Difference (PID)
Time frame: 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).

12 secondary outcomes

PIDs
Time frame: at 15 minutes post-dose.
PIDs
Time frame: at 30 minutes post-dose.
PIDs
Time frame: at 45 minutes post-dose.
PIDs
Time frame: at 60 minutes post-dose.
PIDs
Time frame: at 90 minutes post-dose.
PIDs
Time frame: at 2 hours post-dose.
PIDs
Time frame: at 3 hours post-dose.
PIDs
Time frame: at 4 hours post-dose.
PIDs
Time frame: at 5 hours post-dose.
PIDs
Time frame: at 6 hours post-dose.
PIDs
Time frame: at 7 hours post-dose.
PIDs
Time frame: at 8 hours post-dose.

Results and safety

Results posted to the registry on 28 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Diclofenac HPBCD s.c. 75mg/ml	70	70
Voltarol 75mg/3ml i.m.	72	72

Primary outcome: Pain Intensity Difference (PID)

Time frame: 1.5 hours. Least squares mean (95% Confidence Interval). Unit: mm

Measure	Diclofenac HPBCD s.c. 75mg/ml n = 64	Voltarol 75mg/3ml i.m. n = 65
Value	44.8 (40.5 to 49.1)	45.5 (41.2 to 49.8)

Diclofenac HPBCD s.c. 75mg/ml vs Voltarol 75mg/3ml i.m.: Mean Difference (Final Values): -0.71 (95% CI -6.62 to 5.20), p = 0.813, ANCOVA

Population analysed: 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.

Primary outcome: Pain Intensity Difference (PID)

Time frame: 1.5 hours. Least squares mean (95% Confidence Interval). Unit: mm

Measure	Diclofenac HPBCD s.c. 75mg/ml n = 70	Voltarol 75mg/3ml i.m. n = 71
Value	44.2 (40.0 to 48.3)	44.7 (40.6 to 48.8)

Diclofenac HPBCD s.c. 75mg/ml vs Voltarol 75mg/3ml i.m.: Mean Difference (Final Values): -0.51 (95% CI -6.23 to 5.22), p = 0.862, ANCOVA

Population analysed: 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.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were reported from the signature o fthe informed consent to study end.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Diclofenac HPBCD s.c. 75mg/ml	0 of 70 (0%)	49 of 70 (70%)	Not reported
Voltarol 75mg/3ml i.m.	0 of 72 (0%)	41 of 72 (56.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ian Brook, Prof principal investigator

The school of Clinical Dentistry

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diclofenac HPBCD s.c. 75mg/ml and Voltarol 75mg/3ml i.m. in people with Dental Pain, run by IBSA Institut Biochimique SA at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Difference (PID) (time frame: 1.5 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00943098.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2013.