SB-705498 Dental Pain Study After Tooth Extraction

NCT00281684 | Completed Phase 2 Results

• 1 other identifier: VRA105345
• Study Type: interventional
• Target: 145
• Locations: 3 countries
• Sites: 5

Brief Summary

This clinical trial is a multi centre, randomised, single-blind, parallel group, placebo-controlled, single oral dose study with a positive control arm. Patients previously scheduled for 3rd molar tooth extraction, who are otherwise healthy, will be recruited. Upon completion of surgery, e.g. prior to established pain, patients will be randomised to treatment (SB-706598, placebo or co-codamol) and dosed with the study medication

Conditions

Toothache

Keywords

Acute Pain; Dental Pain; Vanilloid; VR1; TRPV1; Inflammation

Outcome Measures

Primary Outcomes (1)

• Mean of Pain Intensity Based on the Visual Analogue Scale (VAS)

  Pain intensity was assessed using VAS. These assessments were then summarized to give a weighted mean score. The VAS was a subjective assessment of post-operative pain intensity. The participants rated the pain intensity at the time of assessment by marking a line on a 100 millimeter (mm) (0 to 100 mm) long scale. A line placed on the extreme left (0 mm) indicated no pain and extreme right (100 mm) indicated worst pain imaginable. This scale has no subscales. Only those participants available at the specified time points were analyzed.

  Up to 10 hours post-dose

Secondary Outcomes (17)

• Change From Baseline in the Pain Intensity Based on the Verbal Rating Scale (VRS) up to 10 Hours Post Baseline

  Up to 10 hours post Baseline (Day 1)

• Change From Baseline in the Pain Intensity Based on the VAS up to 10 Hours Post-Baseline

  Baseline (Day 1) to 10 hours post Baseline

• Elapsed Time From Study Drug Administration to Rescue Analgesic Request

  Within 24 hours of administration of study drug

• Number of Participants With Different Global Evaluation or Overall Impression of Study Medication Use and at 10 and 24 Hours Post Randomization

  Prior to first rescue medication use and at 10 and 24 hours post randomization

• VAS Mean Pain Scores From the Time of Rescue Medication up to 10 Hours Post Randomization

  From the time of rescue medication to 10 hours post randomization

Study Arms (4)

Placebo

EXPERIMENTAL

Eligible participants received a single dose of SB705498 matching placebo capsules (4 placebo capsules) via oral route and were followed up to a maximum of 14 days.

Drug: Placebo

SB705498 400 mg

EXPERIMENTAL

Eligible participants received a single dose of SB705498 400 milligram (mg) capsules (2 x 200 mg capsules plus 2 placebo capsules) via oral route and were followed up to a maximum of 14 days.

Drug: SB705498 400 mg

SB705498 1000 mg

EXPERIMENTAL

Eligible participants received a single dose of SB705498 1000 mg capsules (2 x 200 mg capsules plus 2 x 300 mg capsules) via oral route and were followed up to a maximum of 14 days.

Drug: SB705498 1000 mg

Co-Codamol

EXPERIMENTAL

Eligible participants received a single dose of Co-codamol capsules (2 x Paracetamol Ph Eur 500 mg, codeine phosphate hemihydrate Ph Eur 12.8 mg plus two placebo capsules) via oral route and were followed up to a maximum of 14 days.

Drug: Co-Codamol

Interventions

SB705498 400 mg DRUG

SB705498 400 mg

SB705498 400 mg

SB705498 1000 mg DRUG

SB705498 1000 mg

SB705498 1000 mg

Placebo DRUG

Placebo

Placebo

Co-Codamol DRUG

Co-Codamol

Co-Codamol

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female or male subjects aged 18 to 50. Women may be of child bearing potential or of non-child bearing potential. Women of child bearing potential must use an effective method of contraception (see below).
• Females of non-child bearing potential are defined as:
• Post-menopausal females, being amenorrhoeic for at least 2 years with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However, if indicated this should be confirmed by oestradiol and FSH levels consistent with menopause (according to local laboratory ranges).
• Pre-menopausal females with a documented hysterectomy (medical report verification) and/or bilateral oophorectomy. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
• Subject is healthy. Healthy subjects are defined as individuals who are not taking any regular medication and are free from clinically significant illness or disease as determined by their medical history (including family history), physical examination, 12-lead ECG, Holter monitor, laboratory studies, and other tests specified in this protocol.
• Subject is scheduled for outpatient surgical removal of up to four third molar teeth under local anesthesia. At least one third molar tooth must be a fully or partially impacted in the mandible requiring bone removal;
• Subject agrees not to take analgesics other than protocol defined rescue analgesics during treatment (up to 24 hrs post dose)
• Subject has the ability to read, comprehend, and record information required by protocol;
• Subject is willing and able to provide signed and dated written informed consent prior to study participation.

You may not qualify if:

• Subject has a history or presence of significant organ disease or mental illness;
• Subject has been exposed to analgesics other than aspirin (including prescription and over the counter NSAIDs or COX-2 inhibitors) within 24 hours prior to the start of surgery;
• Subject is unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g . benzodiazepines) within 24 hours prior to the start of surgery and for the duration of their participation in the study
• Following screening (and 24 h Holter ECG) the subject has a significant abnormality that, in the opinion of the investigator makes them unsuitable for the study.
• Subject with a known allergy to or judged by the investigator not to be a suitable candidate for ibuprofen or co-codamol therapy based on medical history, concomitant medications, and concurrent systemic disease as described in the product labeling, e.g., peptic ulcer disease, angioedema, bronchospastic reactivity (e.g., asthma), rhinitis and nasal polyps induced by aspirin or other NSAIDs;
• The subject had a history of drug or alcohol abuse, or had a positive pre-study urine drug / alcohol breath screen. Abuse of alcohol is defined as an average weekly intake of greater than 21 units or an average daily intake of greater than three units for males and intake greater than 14 units per week or an average daily intake of greater than two units for females. One unit is equivalent to a half-pint (220 mL) of beer or one (25 mL) measure of spirits or one glass (125 mL) of wine.
• Subject has participated, or is participating in, a clinical study in which they have been exposed to an investigational drug or device during the past 30 days;
• Subject has donated blood (450 mL or more) within the previous month.
• Male subjects only:
• An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of the first dose of study medication until five half-lives following administration of the last dose of study medication.
• An unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until 84 days following administration of the last dose of study medication.
• Female subjects of child bearing potential:
• Female subjects who are pregnant, breast feeding, or have a positive serum pregnancy test or a positive urine pregnancy test either at screening or pre-dose on each dosing session.
• An unwillingness of the female subject to use an appropriate form of contraception. Appropriate forms of contraception are defined as:
• Abstinence - The lifestyle of the female should be such that there is complete abstinence from intercourse from at least the commencement of their last normal period prior to the first dose of study medication and to continue until the first normal period (defined as normal for the woman, both in terms of duration and quantity of menses) after treatment or 15 days after the last dose of medication, whichever is the longest.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Verona, Veneto, 37134, Italy

Location

GSK Investigational Site

Seoul, 110-768, South Korea

Location

GSK Investigational Site

Croydon, Surrey, CR7 7YE, United Kingdom

Location

GSK Investigational Site

Leeds, LS2 9NG, United Kingdom

Location

GSK Investigational Site

Manchester, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Toothache; Acute Pain; Inflammation

Interventions

SB 705498; acetaminophen, codeine drug combination

Condition Hierarchy (Ancestors)

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

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 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2006
• First Posted: January 25, 2006
• Study Start: December 7, 2005
• Primary Completion: October 3, 2007
• Study Completion: October 3, 2007
• Last Updated: January 28, 2019
• Results First Posted: January 28, 2019

Record last verified: 2017-09

Locations

KR (1); IT (1); GB (3)