Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386

NCT00672646 | Completed Phase 2 Results

• 1 other identifier: D5090C00010
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive naproxen as control.

Conditions

Pain

Keywords

Analgesic effect

Outcome Measures

Primary Outcomes (1)

• Sum of Pain Intensity Difference in Percent (SPID%)

  Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).

  from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

Secondary Outcomes (5)

• Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)

  Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.

• Time to First Perceptible Pain Relief

  from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

• Time to First Meaningful Pain Relief

  from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours

• VAS Pain Intensity at Rescue Intake

  at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product

• VAS Pain on Jaw Movement at Rescue Intake

  at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product

Study Arms (3)

AZD1386

EXPERIMENTAL

Drug: AZD1386

Naproxen

ACTIVE COMPARATOR

Drug: Naproxen

Placebo

PLACEBO COMPARATOR

Placebo matching AZD1386

Drug: Placebo

Interventions

AZD1386 DRUG

95mg, oral solution, single dose

AZD1386

Naproxen DRUG

500mg, capsule, single dose

Naproxen

Placebo DRUG

AZD1386 Placebo oral solution

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
• Provision of signed informed consent.

You may not qualify if:

• History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
• Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
• A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
• Patients with a body temperature \>37.5°C at Visit 2, before start of surgical procedures

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Pain

Interventions

AZD1386; Naproxen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Gerard Lynch
• Organization: AstraZeneca

aztrial_results_posting@astrazeneca.com

Study Officials

• Lynn Webster, MD

  Lifetree Clinical Research3838 South, 700 East, Suite 202Salt Lake City, Utah 84106, USA

  PRINCIPAL INVESTIGATOR

• Bror Jonzon

  AstraZeneca R&D Södertälje, SE-151 85 Södertälje, Sweden

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2008
• First Posted: May 6, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 8, 2012
• Results First Posted: June 8, 2012

Record last verified: 2012-05

Locations

US (1)