Injectable Diclofenac for the Prevention of Post-operative Dental Pain (DP4)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier:
NCT01706588
First received: October 1, 2012
Last updated: August 28, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Pain
Drug: Diclofenac sodium
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by IBSA Institut Biochimique SA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Postsurgical Extra-oral Swelling [ Time Frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery ] [ Designated as safety issue: No ]
  • Trismus [ Time Frame: measured at 6 hours postsurgery, at day 3 and 1 week postsurgery ] [ Designated as safety issue: No ]
  • Peak Pain Intensity [ Time Frame: measured from end of surgery up to 12 hours postsurgery ] [ Designated as safety issue: No ]
  • Time to First Use of Rescue Medication. [ Time Frame: measured from end of surgery up to 1 week postsurgery ] [ Designated as safety issue: No ]
  • Amount of Rescue Medication [ Time Frame: consumed by the patient every 15-minutes postsurgery up to 6 hours postsurgery ] [ Designated as safety issue: No ]
  • Rescue Medication Consumption [ Time Frame: consumed by the patient from end of surgery up to 24 and up to 48 hours postsurgery ] [ Designated as safety issue: No ]
  • Patient and Investigator Global Evaluation of the Effectiveness of Treatment [ Time Frame: at 6 hour postsurgery and on Day 3 ] [ Designated as safety issue: No ]
  • Time to Onset of Pain [ Time Frame: measured from end of surgery up to 12 hours postsurgery ] [ Designated as safety issue: No ]
  • Wound Healing [ Time Frame: at 6 hour postsurgery, and on day 3 and 1 week postsurgery ] [ Designated as safety issue: Yes ]
  • Recurrent Bleeding [ Time Frame: every hour up to 6 hour postsurgery ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: presurgery (within 30 days from surgery), at day of surgery (day 1), day 3 and 1 week postsurgery. ] [ Designated as safety issue: Yes ]
  • Number of Patients With Adverse Events [ Time Frame: from signature of the informed consent to 1 week postsurgery ] [ Designated as safety issue: Yes ]

Enrollment: 75
Study Start Date: January 2013
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diclofenac sodium 5 mg/mL Drug: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Other Name: Diclofenac HPBCD
Experimental: Diclofenac sodium 12.5 mg/mL Drug: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Other Name: Diclofenac HPBCD
Experimental: Diclofenac sodium 25 mg/mL Drug: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Other Name: Diclofenac HPBCD
Experimental: Diclofenac sodium 50 mg/mL Drug: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Other Name: Diclofenac HPBCD
Placebo Comparator: Placebo 1 mL Drug: Diclofenac sodium
One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
Other Name: Diclofenac HPBCD

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01706588

Locations
United Kingdom
The School of Dentistry University of Birmingham
Birmingham, United Kingdom, B4 6NN
Sponsors and Collaborators
IBSA Institut Biochimique SA
Investigators
Principal Investigator: Thomas Dietrich, MD The School of Dentistry, University of Birmingham
  More Information

No publications provided

Responsible Party: IBSA Institut Biochimique SA
ClinicalTrials.gov Identifier: NCT01706588     History of Changes
Other Study ID Numbers: 12UK/DCsc04
Study First Received: October 1, 2012
Results First Received: August 13, 2014
Last Updated: August 28, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee

Keywords provided by IBSA Institut Biochimique SA:
diclofenac, postsurgical pain, oral surgery

Additional relevant MeSH terms:
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014