PainPhase 2DP4NCT01706588
Injectable Diclofenac for the Prevention of Post-operative Dental Pain
A Phase 2 study testing Diclofenac sodium in people with Pain, run by IBSA Institut Biochimique SA at 1 site in United Kingdom.
Trial summary
This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Diclofenac sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2013to May 2013
- Phase
- Phase 2
- 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
- Out-patients of either gender.
- Patients aged ≥ 18 to ≤ 65 years old.
- Subjects able and willing to give their written consent prior to inclusion in the study.
- Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
- Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
- Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.
Who cannot join
- General
- Patients refusing to give written informed consent.
- Patients not able to understand the purposes of the study or not willing to return for the control visits.
- Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
- Patients enrolled in any clinical trial in the previous 3 months.
- Employees of the study centre with direct involvement in the proposed study or other studies under the direction of the main investigator or study centre, as well as family members of the employees or investigator.
Show all 9Show fewer
- Pregnant or breast-feeding women.
- Alcohol or drug abuse in the previous 12 months.
- Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The School of Dentistry University of Birmingham
Birmingham, B4 6NN
About this study
Official title: Preliminary Evaluation of the Efficacy and Local Tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, Administered Locally Prior to Surgery for the Prevention of Post-operative Pain After Third Molar Surgery
This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.
- Conditions
- Pain
- Being tested
- Diclofenac sodium
- Keywords
- diclofenac, postsurgical pain, oral surgery
- Medical subject headings
- Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac sodiumDrug
Also called Diclofenac HPBCD
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
| Study group | Role | What they receive |
|---|---|---|
| Diclofenac sodium 5 mg/mL | Experimental | Not described Receives: Drug: Diclofenac sodium |
| Diclofenac sodium 12.5 mg/mL | Experimental | Not described Receives: Drug: Diclofenac sodium |
| Diclofenac sodium 25 mg/mL | Experimental | Not described Receives: Drug: Diclofenac sodium |
| Diclofenac sodium 50 mg/mL | Experimental | Not described Receives: Drug: Diclofenac sodium |
| Placebo 1 mL | Placebo comparator | Not described Receives: Drug: Diclofenac sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of the Pain Scores.
Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
Measured: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
Secondary outcomes (12)
Postsurgical Extra-oral Swelling
Measured: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Trismus
Measured: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Peak Pain Intensity
Measured: measured from end of surgery up to 12 hours postsurgery
Time to First Use of Rescue Medication.
Measured: measured from end of surgery up to 1 week postsurgery
Amount of Rescue Medication
Measured: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
Rescue Medication Consumption
Measured: consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
Patient and Investigator Global Evaluation of the Effectiveness of Treatment
Measured: at 6 hour postsurgery and on Day 3
Time to Onset of Pain
Measured: measured from end of surgery up to 12 hours postsurgery
Wound Healing
Measured: at 6 hour postsurgery, and on day 3 and 1 week postsurgery
Recurrent Bleeding
Measured: every hour up to 6 hour postsurgery
Vital Signs
Measured: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
Number of Patients With Adverse Events
Measured: from signature of the informed consent to 1 week postsurgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2013
- Study completionMay 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Institut Biochimique SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Dietrich, MD, Principal investigator, The School of Dentistry, University of Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706588
- Sponsor's protocol ID
- 12UK/DCsc04
- Acronym
- DP4
- Status last verified
- Aug 2014
- First submitted
- 1 Oct 2012
- Last updated
- 5 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gorecki P, Rainsford KD, Taneja P, Bulsara Y, Pearson D, Saund D, Ahmed B, Dietrich T. Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial. J Dent Res. 2018 Apr;97(4):381-387. doi: 10.1177/0022034517744207. Epub 2017 Dec 4.
PubMed 29202646
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of the Efficacy and Local Tolerability of Injectable Diclofenac at 5, 12.5, 25 and 50 mg/mL, Administered Locally Prior to Surgery for the Prevention of Post-operative Pain After Third Molar Surgery
- ClinicalTrials.gov ID
- NCT01706588
- Acronym / sponsor ID
- DP4 / 12UK/DCsc04
- Conditions
- Pain
- Keywords
- diclofenac, postsurgical pain, oral surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- IBSA Institut Biochimique SAIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Posted 28 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomised, double-blind, placebo-controlled, parallel group study in approximately 75 patients undergoing surgical removal of an impacted lower third molar.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Diclofenac sodium 5 mg/mL | Experimental | Drug: Diclofenac sodium |
| Diclofenac sodium 12.5 mg/mL | Experimental | Drug: Diclofenac sodium |
| Diclofenac sodium 25 mg/mL | Experimental | Drug: Diclofenac sodium |
| Diclofenac sodium 50 mg/mL | Experimental | Drug: Diclofenac sodium |
| Placebo 1 mL | Placebo comparator | Drug: Diclofenac sodium |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Out-patients of either gender.
- Patients aged ≥ 18 to ≤ 65 years old.
- Subjects able and willing to give their written consent prior to inclusion in the study.
- Female subjects of childbearing potential must (1) have a negative urine pregnancy test at the inclusion visit, (2) be using an appropriate method of contraception according to the definition of Note of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner), and (3) be willing to continue using the contraceptive method throughout the entire study period.
- Subjects must (1) be able to comprehend the full nature and purpose of the study, including possible risks and side effects, (2) fully co-operate with the Investigator, (3) comply with the requirements of the entire study.
Key exclusion criteria (9 listed)
- General
- Patients refusing to give written informed consent.
- Patients not able to understand the purposes of the study or not willing to return for the control visits.
- Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
- Patients enrolled in any clinical trial in the previous 3 months.
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 sodiumAlso: Diclofenac HPBCDOne single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect. | Drug | Diclofenac sodium 12.5 mg/mL, Diclofenac sodium 25 mg/mL, Diclofenac sodium 5 mg/mL, Diclofenac sodium 50 mg/mL, Placebo 1 mL |
Primary outcome
Area Under the Curve (AUC) of the Pain Scores.
Time frame: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
Pain will be scored by the patient at the end of surgery (time 0) and at 15-minute intervals after surgery for a total of 6 hours on a 0-100 mm VAS (from 0 = no pain to 100 = worst pain imaginable).
12 secondary outcomes
Postsurgical Extra-oral Swelling
Time frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Trismus
Time frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery
Peak Pain Intensity
Time frame: measured from end of surgery up to 12 hours postsurgery
Time to First Use of Rescue Medication.
Time frame: measured from end of surgery up to 1 week postsurgery
Amount of Rescue Medication
Time frame: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery
Rescue Medication Consumption
Time frame: consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery
Patient and Investigator Global Evaluation of the Effectiveness of Treatment
Time frame: at 6 hour postsurgery and on Day 3
Time to Onset of Pain
Time frame: measured from end of surgery up to 12 hours postsurgery
Wound Healing
Time frame: at 6 hour postsurgery, and on day 3 and 1 week postsurgery
Recurrent Bleeding
Time frame: every hour up to 6 hour postsurgery
Vital Signs
Time frame: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.
Number of Patients With Adverse Events
Time frame: from signature of the informed consent to 1 week postsurgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29202646Gorecki P, Rainsford KD, Taneja P, Bulsara Y, Pearson D, Saund D, Ahmed B, Dietrich T. Submucosal Diclofenac for Acute Postoperative Pain in Third Molar Surgery: A Randomized, Controlled Clinical Trial. J Dent Res. 2018 Apr;97(4):381-387. doi: 10.1177/0022034517744207. Epub 2017 Dec 4.
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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, MD principal investigator
The School of Dentistry, University of Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Diclofenac sodium in people with Pain, run by IBSA Institut Biochimique SA at 1 site 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 6 inclusion and 9 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 5 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Aug 2014). 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?
Area Under the Curve (AUC) of the Pain Scores. (time frame: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery). 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 NCT01706588, which also lists 1 linked publication.
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 5 Sep 2014.