NCT00659490

Brief Summary

The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for phase_2 pain

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

June 11, 2012

Status Verified

May 1, 2010

Enrollment Period

3 months

First QC Date

April 10, 2008

Results QC Date

May 4, 2010

Last Update Submit

June 5, 2012

Conditions

Pain

Keywords

Analgesic effectMolar extraction

Outcome Measures

Primary Outcomes (1)

  • Pain Area Under the Curve 0-8h (AUC0-8h)

    Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.

    0-8 h(from end of surgery to 8 hours post surgery)

Secondary Outcomes (21)

  • Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)

    0-4h (from end of surgery to 4 hours post surgery)

  • Maximum Pain Based on VAS Scale

    From end of surgery to 8h or time first intake of rescue medication (whichever came first)

  • Mean Pain Based on a VAS Scale

    From end of surgery to 8h or time to first intake of rescue medication (whichever came first)

  • Pain at Jaw Movement AUC0-8h

    0-8h from end of surgery to 8 hours post surgery

  • Pain at Jaw Movement AUC0-4h

    0-4h after end of surgery to 4 hours post surgery

  • +16 more secondary outcomes

Study Arms (3)

AZD1940

EXPERIMENTAL

AZD1940 800ug given predose

Drug: AZD1940

Naproxen

ACTIVE COMPARATOR

Naproxen 500mg given pre-surgery

Drug: Naproxen

Placebo

PLACEBO COMPARATOR

Placebo given pre-surgery

Drug: Placebo

Interventions

AZD1940DRUG

800ug oral administration

AZD1940
NaproxenDRUG

500mg oral administration

Also known as: Naprosyn
Naproxen
PlaceboDRUG

Placebo given pre-surgery

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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.
  • Healthy males or non-fertile females.

You may not qualify if:

  • History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
  • History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Salt Lake City, Utah, United States

Location

MeSH Terms

Conditions

Pain

Interventions

N-(2-tert-butyl-1-((4,4-difluorocyclohexyl)methyl)-1H-benzo(d)imidazol-5-yl)ethanesulfonamideNaproxen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic 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

April 10, 2008

First Posted

April 16, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 11, 2012

Results First Posted

March 26, 2012

Record last verified: 2010-05

Locations

US(1)