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CompletedNCT01706588DP4Updated Sep 5, 2014Results posted

Injectable Diclofenac for the Prevention of Post-operative Dental Pain

A Phase 2 interventional study of Diclofenac sodium in Pain, sponsored by IBSA Institut Biochimique SA. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-09-05.

Sponsored by IBSA Institut Biochimique SA · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Pain

Keywords

  • diclofenac, postsurgical pain, oral surgery
03

In context

Lead sponsor

IBSA Institut Biochimique SA is the lead sponsor of 33 studies on the registry; 1 is open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Out-patients of either gender.
  2. Patients aged ≥ 18 to ≤ 65 years old.
  3. Subjects able and willing to give their written consent prior to inclusion in the study.
  4. 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.
  5. 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.
  6. Patients undergoing surgical extraction of a single, fully or partially impacted mandibular 3rd molar requiring bone removal.

Exclusion criteria

Exclusion Criteria:

General

  1. Patients refusing to give written informed consent.
  2. Patients not able to understand the purposes of the study or not willing to return for the control visits.
  3. Patients with major psychiatric disorders that, in the investigator's opinion, could compromise study participation.
  4. Patients enrolled in any clinical trial in the previous 3 months.
  5. 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.
  6. Pregnant or breast-feeding women.
  7. Alcohol or drug abuse in the previous 12 months.
  8. Clinically significant or unstable concomitant disease whose sequelae might interfere with the study evaluation parameters.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    Diclofenac sodium 5 mg/mL

    Drug: Diclofenac sodium

  • Experimental
    Diclofenac sodium 12.5 mg/mL

    Drug: Diclofenac sodium

  • Experimental
    Diclofenac sodium 25 mg/mL

    Drug: Diclofenac sodium

  • Experimental
    Diclofenac sodium 50 mg/mL

    Drug: Diclofenac sodium

  • Placebo comparator
    Placebo 1 mL

    Drug: Diclofenac sodium

Interventions

  • DrugDiclofenac sodium

    One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.

    Also known as: Diclofenac HPBCD

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery

Secondary outcomes

  1. Postsurgical Extra-oral Swelling

    Time frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery

  2. Trismus

    Time frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery

  3. Peak Pain Intensity

    Time frame: measured from end of surgery up to 12 hours postsurgery

  4. Time to First Use of Rescue Medication.

    Time frame: measured from end of surgery up to 1 week postsurgery

  5. Amount of Rescue Medication

    Time frame: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery

  6. Rescue Medication Consumption

    Time frame: consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery

  7. Patient and Investigator Global Evaluation of the Effectiveness of Treatment

    Time frame: at 6 hour postsurgery and on Day 3

  8. Time to Onset of Pain

    Time frame: measured from end of surgery up to 12 hours postsurgery

  9. Wound Healing

    Time frame: at 6 hour postsurgery, and on day 3 and 1 week postsurgery

  10. Recurrent Bleeding

    Time frame: every hour up to 6 hour postsurgery

  11. Vital Signs

    Time frame: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.

  12. Number of Patients With Adverse Events

    Time frame: from signature of the informed consent to 1 week postsurgery

07

Results

Posted Aug 28, 2014

Participant flow

Participant flow — Overall Study
MilestoneDiclofenac Sodium 5 mg/mLDiclofenac Sodium 12.5 mg/mLDiclofenac Sodium 25 mg/mLDiclofenac Sodium 50 mg/mLPlacebo 1 mL
Started1515151416
Completed1515151416
Not completed00000

Outcome measures

PrimaryArea 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).

Time frame:
Pain scores will be measured over the time from end of surgery (time 0) to the 6 hour post-surgery
Reported as:
Mean · mm*minutes
Area Under the Curve (AUC) of the Pain Scores.
mm*minutesDiclofenac Sodium 5 mg/mLDiclofenac Sodium 12.5 mg/mLDiclofenac Sodium 25 mg/mLDiclofenac Sodium 50 mg/mLPlacebo 1 mL
Area Under the Curve (AUC) of the Pain Scores.6843 ± 62598832 ± 63309998 ± 80807290 ± 650915539 ± 9279
SecondaryPostsurgical Extra-oral Swelling
Time frame:
measured at 6 hours postsurgery, at day 3 and 1 week postsurgery

Results for this outcome have not been posted.

SecondaryTrismus
Time frame:
measured at 6 hours postsurgery, at day 3 and 1 week postsurgery

Results for this outcome have not been posted.

SecondaryPeak Pain Intensity
Time frame:
measured from end of surgery up to 12 hours postsurgery

Results for this outcome have not been posted.

SecondaryTime to First Use of Rescue Medication.
Time frame:
measured from end of surgery up to 1 week postsurgery

Results for this outcome have not been posted.

SecondaryAmount of Rescue Medication
Time frame:
consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery

Results for this outcome have not been posted.

SecondaryRescue Medication Consumption
Time frame:
consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery

Results for this outcome have not been posted.

SecondaryPatient and Investigator Global Evaluation of the Effectiveness of Treatment
Time frame:
at 6 hour postsurgery and on Day 3

Results for this outcome have not been posted.

SecondaryTime to Onset of Pain
Time frame:
measured from end of surgery up to 12 hours postsurgery

Results for this outcome have not been posted.

SecondaryWound Healing
Time frame:
at 6 hour postsurgery, and on day 3 and 1 week postsurgery

Results for this outcome have not been posted.

SecondaryRecurrent Bleeding
Time frame:
every hour up to 6 hour postsurgery

Results for this outcome have not been posted.

SecondaryVital Signs
Time frame:
presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery.

Results for this outcome have not been posted.

SecondaryNumber of Patients With Adverse Events
Time frame:
from signature of the informed consent to 1 week postsurgery

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Diclofenac Sodium 5 mg/mL—0/15 (0%)6/15 (40%)
Diclofenac Sodium 12.5 mg/mL—0/15 (0%)7/15 (46.7%)
Diclofenac Sodium 25 mg/mL—0/15 (0%)5/15 (33.3%)
Diclofenac Sodium 50 mg/mL—0/14 (0%)5/14 (35.7%)
Placebo 1 mL—0/16 (0%)6/16 (37.5%)
Most frequent other events
Showing 10 of 19
Most frequent other events
EventDiclofenac Sodium 5 mg/mLDiclofenac Sodium 12.5 mg/mLDiclofenac Sodium 25 mg/mLDiclofenac Sodium 50 mg/mLPlacebo 1 mL
injection site painGeneral disorders2/152/154/151/140/16
headacheNervous system disorders4/150/150/151/142/16
pain in jawMusculoskeletal and connective tissue disorders0/154/150/150/142/16
ear painEar and labyrinth disorders2/151/150/151/140/16
vomitingGastrointestinal disorders2/150/152/150/141/16
dizzinessNervous system disorders0/152/150/150/140/16
injection site swellingGeneral disorders0/150/152/150/140/16
nauseaGastrointestinal disorders0/150/150/151/142/16
linphadenopathyBlood and lymphatic system disorders0/150/150/151/140/16
gingival ulcerationGastrointestinal disorders0/150/150/151/140/16

Baseline characteristics

Age, Continuous
Age, Continuous(years)Diclofenac Sodium 5 mg/mLDiclofenac Sodium 12.5 mg/mLDiclofenac Sodium 25 mg/mLDiclofenac Sodium 50 mg/mLPlacebo 1 mLTotal
Mean28 ± 7.328 ± 9.430 ± 927 ± 4.530 ± 9.528.6 ± 7.94
Sex: Female, Male
Sex: Female, Male(Participants)Diclofenac Sodium 5 mg/mLDiclofenac Sodium 12.5 mg/mLDiclofenac Sodium 25 mg/mLDiclofenac Sodium 50 mg/mLPlacebo 1 mLTotal
Female961281247
Male6936428
08

Study locations

1 site
  • The School of Dentistry University of Birmingham
    Birmingham, B4 6NN, United Kingdom
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01706588
Lead sponsor
IBSA Institut Biochimique SA
Responsible party
Sponsor
First posted
Oct 15, 2012
Start date
Jan 2013
Primary completion
May 2013
Completion
May 2013
Results posted
Aug 28, 2014
Last update
Sep 5, 2014

Study contacts

Thomas Dietrich, MD
principal investigator · The School of Dentistry, University of Birmingham

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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