Post-operative Dental Pain Study Comparing Two Different Dosage of Analgesic Efficacy

NCT01075243 | Completed Phase 4 Results

• 1 other identifier: A4000685
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 1

Brief Summary

GlaxoSmithKline will be conducting this trial to compare analgesic efficacy of paracetamol 1000 mg vs 650 mg. The post-surgical dental pain model will be used to evaluate the analgesic efficacy of paracetamol. Each subject will be enrolled in the study for up to six weeks. The duration of the entire study will be approximately 18 weeks. Each subject will have to come to the clinic for three visits (Screening, Treatment and Follow up visits).

Conditions

Post-surgical Dental Pain

Keywords

dental pain; paracetamol; Post-surgical dental pain

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Relief and Pain Intensity Differences From 0 to 6 Hours (SPRID 6 Hours)

  SPRID:Sum of Pain Intensity Difference (SPID) and Total Pain Relief (TOTPAR) at each post-dosing time-point. SPRID score ranged from -5.8 (least pain relief) to 40.3 (highest pain relief). SPID and TOTPAR were calculated as weighted sums of Pain Intensity Differences (PID) and Pain Relief Scores (PRS) at each measurement time, respectively. PID was derived by subtracting the pain severity score at a given post-dosing time-point from the baseline \[pain severity score range:0-no pain, 1-mild pain, 2-moderate pain, 3-severe pain using a 4-point categorical Verbal Rating Scale (VRS)\]. If the subject rated pain intensity as 2 or 3, pain was assessed using a 100 mm Visual Analog Scale (VAS) \[0 (no pain), 100 (worst pain)\]. VAS scores were converted into PID scores by subtracting them from baseline pain scores. PRS was assessed on 5-point categorical pain relief rating scale \[0-no relief, 1-little relief, 2-some relief, 3-a lot of relief, 4-complete relief\]

  Every two hours from Baseline to 6 hours post dose

Secondary Outcomes (14)

• Time to Confirmed First Perceptible Relief

  Baseline to 6 hours post dose

• Time to Onset of Meaningful Pain Relief

  Baseline to 6 hours post dose

• Time to Start Using Rescue Medication

  Baseline to 6 hours post dose

• Percentage of Participants Who Took Rescue Medication at 2 Hours

  Baseline to 2 hours post dose

• Percentage of Participants Who Took Rescue Medication at 6 Hours

  Baseline to 6 hours post dose

Study Arms (3)

Paracetamol 1000mg

EXPERIMENTAL

Paracetamol 1000mg

Drug: Paracetamol 1000 mg

Paracetamol 650 mg

EXPERIMENTAL

Paracetamol 650 mg

Drug: Paracetamol 650 mg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Paracetamol 1000 mg DRUG

Paracetamol 1000mg

Paracetamol 1000mg

Paracetamol 650 mg DRUG

Paracetamol 650 mg

Paracetamol 650 mg

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged 18 to 45 years with moderate-to-severe dental pain as assessed by verbal rating scale (VRS) and confirmed by a score of at least 50 mm out of 100 mm using a visual analogue (VAS) following the surgical removal of up to two mandibular third molars. If only one mandibular third molar is removed, it must be a full bony impaction. If two mandibular third molars are removed, both may be partial bony impactions OR there may be a combination of one full bony impaction with the second tooth being erupted, soft tissue impaction, or partial bony impaction. Ipsilateral maxillary third molars may be removed at the surgeon's discretion, regardless of impaction level.

You may not qualify if:

• Pregnant and lactating females
• Allergy/intolerance to study materials or nitrous oxide or local anaesthetic used during surgery
• Current or recurrent liver, kidney or cardiac disease, stomach ulcers, gastrointestinal bleeding, gastroesophageal reflux disease, bronchospasm, rhinitis, urticaria or asthma

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Jean Brown Research

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

• Yue Y, Collaku A, Brown J, Buchanan WL, Reed K, Cooper SA, Otto J. Efficacy and speed of onset of pain relief of fast-dissolving paracetamol on postsurgical dental pain: two randomized, single-dose, double-blind, placebo-controlled clinical studies. Clin Ther. 2013 Sep;35(9):1306-20. doi: 10.1016/j.clinthera.2013.07.422. Epub 2013 Aug 22.

  PMID: 23972577 DERIVED

MeSH Terms

Conditions

Toothache

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: November 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: April 29, 2015
• Results First Posted: April 29, 2015

Record last verified: 2015-04

Locations

US (1)