Dental PainPhase 3NCT00942448
Evaluation of the Efficacy and Safety of Diclofenac HPBCD 25, 50 mg/ml in the Treatment of Post-surgical Pain Following Dental Surgery
A Phase 3 study testing Diclofenac HPBCD in people with Dental Pain, run by IBSA Institut Biochimique SA at 6 sites in 2 countries.
Trial 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. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 306 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Sep 2009to Apr 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.
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- 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
6 sites in 2 countries.
6 sites in 2 countries
Poland4 sites
Gabinet Stomatologiczny Bartek
Kobyłka, 05-230
Centrum Leczenia Chorób Cywilizacyjnych
Warsaw, 02-797
Niepubliczny Zakład Opieki Zdrowotnej
Warsaw, 03-252
NZOZ Polimedica
Zgierz, 95-100
United Kingdom2 sites
The School of Dentistry; University of Birmingham
Birmingham, B4 6NN
Eastman Dental Institute, University College London
London, WC1X8LD
About this study
Official title: Efficacy and Safety Study of Diclofenac HPBCD 25, 50 mg/ml Administered as Single s.c. Dose, in the Treatment of Acute Moderate-to-severe Post-surgical Pain From Dental Surgery (Impacted 3rd Molar Extraction)
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
- Being tested
- Diclofenac HPBCD, Placebo s.c.
- Medical subject headings
- Toothache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac HPBCDDrug
1 single injection at day of dental surgical extraction
Diclofenac HPBCDDrug
1 single injection at day of dental surgical extraction
Diclofenac HPBCDDrug
1 single injection at day of dental surgical extraction
Placebo s.c.Other
1 single injection at day of dental surgical extraction
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac HPBCD s.c. 25mg/ml | Experimental | Not described Receives: Drug: Diclofenac HPBCD |
| Diclofenac HPBCD s.c. 50mg/ml | Experimental | Not described Receives: Drug: Diclofenac HPBCD |
| Diclofenac HPBCD s.c. 75mg/ml | Active comparator | Not described Receives: Drug: Diclofenac HPBCD |
| Placebo s.c. (1ml) | Placebo comparator | Not described Receives: Other: Placebo s.c. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at 1.5 hours after treatment administration
Secondary outcomes (12)
PID
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).
Measured: at 15 minutes post-dose.
PID
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).
Measured: at 30 minutes post-dose.
PID
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).
Measured: at 45 minutes post-dose.
PID
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).
Measured: at 60 minutes post-dose.
PID
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).
Measured: at 90 minutes post-dose.
PID
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).
Measured: at 2 hours post-dose.
PID
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).
Measured: at 3 hours post-dose.
PID
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).
Measured: at 4 hours post-dose.
PID
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).
Measured: at 5 hours post-dose.
PID
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).
Measured: at 6 hours post-dose.
PID
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).
Measured: at 7 hours post-dose.
PID
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).
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.
- First posted21 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionApr 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
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Dietrich, Prof, Principal investigator, The school of dentistry, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942448
- Sponsor's protocol ID
- 09PUK-DCsc04
- Status last verified
- Feb 2011
- First submitted
- 17 Jul 2009
- Last updated
- 28 Jan 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Study of Diclofenac HPBCD 25, 50 mg/ml Administered as Single s.c. Dose, in the Treatment of Acute Moderate-to-severe Post-surgical Pain From Dental Surgery (Impacted 3rd Molar Extraction)
- ClinicalTrials.gov ID
- NCT00942448
- Acronym / sponsor ID
- 09PUK-DCsc04
- Conditions
- Dental Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
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 HPBCD1 single injection at day of dental surgical extraction | Drug | Diclofenac HPBCD s.c. 25mg/ml |
| Diclofenac HPBCD1 single injection at day of dental surgical extraction | Drug | Diclofenac HPBCD s.c. 50mg/ml |
| Diclofenac HPBCD1 single injection at day of dental surgical extraction | Drug | Diclofenac HPBCD s.c. 75mg/ml |
| Placebo s.c.1 single injection at day of dental surgical extraction | Other | Placebo s.c. (1ml) |
Primary outcome
Pain Intensity Difference (PID) on a 0-100 VAS
Time frame: at 1.5 hours after treatment administration
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).
12 secondary outcomes
PID
Time frame: at 15 minutes post-dose.
PID
Time frame: at 30 minutes post-dose.
PID
Time frame: at 45 minutes post-dose.
PID
Time frame: at 60 minutes post-dose.
PID
Time frame: at 90 minutes post-dose.
PID
Time frame: at 2 hours post-dose.
PID
Time frame: at 3 hours post-dose.
PID
Time frame: at 4 hours post-dose.
PID
Time frame: at 5 hours post-dose.
PID
Time frame: at 6 hours post-dose.
PID
Time frame: at 7 hours post-dose.
PID
Time frame: at 8 hours post-dose.
Results and safety
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.
Thomas Dietrich, Prof principal investigator
The school of dentistry, University of Birmingham
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diclofenac HPBCD in people with Dental Pain, run by IBSA Institut Biochimique SA at 6 sites in 2 countries.
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 6 sites in Poland, 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. Some participants in this study may receive a placebo. 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) on a 0-100 VAS (time frame: at 1.5 hours after treatment administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.