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A Study to Assess the Efficacy and Tolerability of Diclofenac Potassium Soft Gelatin Capsules Compared With Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain

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ClinicalTrials.gov Identifier: NCT02476422
Recruitment Status : Completed
First Posted : June 19, 2015
Results First Posted : October 17, 2016
Last Update Posted : October 17, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The study is designed to assess the efficacy and tolerability of diclofenac potassium soft gelatin capsules compared with ibuprofen tablets in patients with moderate to severe postoperative dental pain.

Condition or disease Intervention/treatment Phase
Post Operative Dental Pain Drug: Diclofenac potassium Drug: Ibuprofen Drug: Placebo to ibuprofen Drug: Placebo to diclofenac potassium Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 328 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Tolerability of 50 mg Diclofenac Potassium Soft Gelatin Capsules Compared With 400 mg Ibuprofen Tablets in Patients With Moderate to Severe Postoperative Dental Pain
Study Start Date : April 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015


Arm Intervention/treatment
Experimental: Dilcofenac potassium + placebo to Ibuprofen
Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
Drug: Diclofenac potassium
Single dose of diclofenac 50 mg soft gelatin capsule
Other Name: diclofenac-K

Drug: Placebo to ibuprofen
Single dose of placebo to ibuprofen 400 mg tablet
Other Name: Placebo

Active Comparator: Ibuprofen + placebo to diclofenac potassium
Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
Drug: Ibuprofen
Single dose of ibuprofen 400 mg tablet
Other Name: Ibuprofen acid

Drug: Placebo to diclofenac potassium
Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule
Other Name: Placebo




Primary Outcome Measures :
  1. Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at 60 Minutes Post Dose [ Time Frame: 60 minutes postdose ]
    VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change represents a reduction in pain.


Secondary Outcome Measures :
  1. Change From Baseline in Visual Analog Scale of Pain Intensity (VASPI) at Different Time Points [ Time Frame: 15, 30, 45, and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose ]
    VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their current level of pain intensity on the 100 mm VASPI, labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change represents a reduction in pain.

  2. Area Under the Curve (AUC) of Visual Analog Scale of Pain Intensity (VASPI) Measuring Change From Baseline at Different Time Points [ Time Frame: 15, 30, 45, 60 and 90 minutes, and 2, 4, 5, 6, 7, and 8 hours post dose ]

    VASPI reduction from baseline is the difference between the Baseline VASPI score and the VASPI score at a specific observation point. Subjects were asked to identify their pain intensity using the 100 mm VASPI to indicate their current level of pain intensity on the 100 mm VASPI labeled "no pain" (0 mm) as the left anchor and "worst possible pain" (100 mm) as the right anchor. A positive change shows reduction in pain.

    AUC of VASPI reduction from baseline for each time point was calculated using the trapezoidal rule.


  3. Time to Confirmed First Perceptible Pain Relief [ Time Frame: Within 8 hours postdose ]
    Time to onset of first perceptible pain relief (FPR), provided the FPR was subsequently 'confirmed' through the achievement of meaningful pain relief (MPR). Participant started two stopwatches at dosing, and recorded FPR by stopping the first stopwatch when he/she first experienced 'any' pain relief. FPR is 'confirmed' only if the participant also stopped the second stopwatch indicating 'meaningful pain relief'.

  4. Time to Onset of Meaningful Pain Relief (MPR) [ Time Frame: Within 8 hours postdose ]
    Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the second stopwatch as soon as he/she began to experience 'meaningful' relief from pain. Time elapsed is recorded as the MPR.

  5. Time to Onset of First Perceptible Pain Relief (FPR) [ Time Frame: Within 8 hours postdose ]
    Using the double stopwatch technique, participant started two stopwatches at dosing, and stopped the first stopwatch as soon as he/she first began to feel 'any' relief from pain. The time elapsed was recorded as the FPR.

  6. Sum of Pain Intensity Difference (SPID) [ Time Frame: 1, 2, 4, 6, and 8 hours postdose ]
    At baseline and at each defined study time point, the clinical site staff captured pain intensity information from each subject using the 4-point categorical VRS. The subject was asked "What is your pain level at this time?" and the response was recorded as 0 = none, 1 = mild, 2 = moderate, and 3 = severe. Pain intensity difference (PID) was the difference between the baseline pain intensity score and the pain intensity score at a specific observation point. SPID is the weighted sum of PIDs from the 15-minute to the 8-hour observation point (SPID8). Additionally, SPID evaluations were also be done at 1 (SPID1), 2 (SPID2), 4 (SPID4) and 6 (SPID6) hours post dose. The weights used for these values were 0.25 for the 15-, 30-, 45-, and 60-minute observations, and 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations.

  7. Summed Total Pain Relief (TOTPAR) at Different Time Points [ Time Frame: 1, 2, 4, 6, and 8 hours postdose ]

    After the administration of the single dose of the assigned study treatment, at the defined study time points, the clinical site staff captured pain relief information from each subject.

    The subject was asked "What is the amount of pain relief as compared to the starting pain?" and the response was recorded as 0 = none, 1 = a little, 2 = some, 3 = a lot, or 4 = complete.

    Total pain relief (TOTPAR) was the weighted sum of the pain relief scores from the 15-minute to the 8-hour observation points (TOTPAR8). Additionally, TOTPARs at 1, 2, 4 and 6 hours were calculated. The weights used for these values (evaluation time points) were 0.25 for the 15-, 30-, 45-, and 60-minute observations, 0.5 for the 90-minute, 2- and 4-hour observations, and 1 for the remaining observations.


  8. Peak Analgesic Effect [ Time Frame: From dose administration to 8 hours post dose ]
    Peak analgesic relief is represented through highest pain intensity difference (PID), highest VASPI reduction, and highest pain relief scores. Pain intensity was measured on a verbal rating scale (VRS) ranging from 0 to 3 (none to severe, with higher score for higher pain intensity). PID represents difference in this score at baseline and specific time points, larger change indicating larger reduction in pain, with highest PID representing the largest difference. Pain relief was recorded on a scale ranging from 0 to 4 (none to complete, with higher score for higher pain relief), with highest pain relief representing maximum relief obtained. Pain intensity was also measured through a 100 mm visual analogue scale (VASPI), ranging from "no pain" (0 mm) to "worst possible pain" (100 mm). A positive change in VASPI indicates reduction in pain, with highest VASPI reduction representing highest change.

  9. Duration of Analgesia [ Time Frame: From dose administration to 8 hours post dose ]
    Duration of analgesia (time to first use of rescue medication) was evaluated, from dose administration to the time of first use of rescue medication within the 8-hour treatment period. Censored observations were included in calculating this endpoint. Censored subjects include any subject who did not take rescue medication prior to the end of the assessment period of 480 minutes (8 hours).

  10. Number of Patients Needing Rescue Medication [ Time Frame: From dose administration to 8 hours post dose ]
    The number of patients needing rescue medication within the 8 hour treatment period was evaluated.

  11. Number of Patients With Different Responses Based on Patient's Global Assessment of Response to Treatment (PGART) [ Time Frame: At 8 hour postdose prior to use of rescue medication ]
    PGART was measured by asking patients to give a score on a scale from 0 to 4, where 0 = poor; 1 = fair; 2 = good; 3 = very good; 4 = excellent. This measurement was taken at the end of 8 hours, or before the use of rescue medication (for a patient who takes rescue medciation within the 8 hour period).

  12. Number of Patients With Any Adverse Events, Serious Adverse Events and Death [ Time Frame: time of dosage administration up to the follow-up phone call on study Day 3 (maximum 3 days) ]
    Treatment emergent adverse events are reported in the below data table.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Patients requiring surgical removal of 2 ipsilateral third molars, of which the mandibular must be fully or partially impacted. The ipsilateral maxillary third molar may be of any impaction level.
  • Patients having a moderate to severe Baseline pain intensity as assessed by a score of 2 (moderate) or 3 (severe) on the 4-point categorical pain intensity VRS, confirmed by a VASPI score of ≥ 50 mm within 5 hours of surgical completion, after local anesthetic dissipation.

Key Exclusion Criteria:

  • Patients who require the removal of a single third molar, or 2 ipsilateral third molars where mandibular molar is not fully or partially impacted.
  • Patients with active peptic ulcer disease or a history of significant gastrointestinal disease or any gastrointestinal bleeding.
  • Patients with coagulation or bleeding disorders.
  • Patients with a positive drug or alcohol screen.
  • Patients who have received an anti-inflammatory agent, analgesic, sedative, hypnotic, muscle relaxant, or tranquilizer within 5 elimination half-lives before administration of study drug (other than surgical anesthetic prior to and during dental surgery).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02476422


Locations
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United States, Texas
Novartis Investigative Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02476422     History of Changes
Other Study ID Numbers: CCAT458M2402
First Posted: June 19, 2015    Key Record Dates
Results First Posted: October 17, 2016
Last Update Posted: October 17, 2016
Last Verified: August 2016
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Diclofenac potassium
Post-operative dental pain
Moderate to severe pain
Additional relevant MeSH terms:
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Diclofenac
Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action