NCT01035346

Brief Summary

This single-dose trial will evaluate the efficacy of a novel ibuprofen formulation compared to placebo in patients with a fever due to an uncomplicated acute infection.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

December 8, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

August 21, 2012

Completed
Last Updated

August 21, 2012

Status Verified

July 1, 2012

Enrollment Period

1.3 years

First QC Date

December 8, 2009

Results QC Date

July 13, 2012

Last Update Submit

July 13, 2012

Conditions

Infection

Keywords

Feverantipyreticuncomplicated acute viral infectionuncomplicated acute bacterial infections

Outcome Measures

Primary Outcomes (1)

  • Time-weighted Sum of The Temperature Differences From Baseline Through Hour 6 (STEMPD 0-6)

    STEMPD 0-6 was defined as time-weighted sum of temperature differences over 6 hours, weighted by the time elapsed between each 2 consecutive time points. Temperature difference was defined as baseline temperature minus post-baseline temperature at each time point, where positive value indicated improvement in body temperature.

    0 to 6 hours

Secondary Outcomes (6)

  • Time-weighted Sum of The Temperature Differences From Baseline Through Hour 4 and Hour 8 (STEMPD 0-4 and STEMPD 0-8)

    0 to 4, 0 to 8 hours

  • Change From Baseline in Temperature at Hours 0.25, 0.5, 1, 2, 4, 6 and 8

    Baseline, 0.25, 0.5, 1, 2, 4, 6, 8 hours

  • Time to Treatment Failure

    0 to 8 hours

  • Cumulative Percentage of Participants With Treatment Failure

    0.25, 0.5, 1, 2, 4, 6, 8 hours

  • Global Assessment of Study Medication as an Antipyretic

    8 hours

  • +1 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: Ibuprofen

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

IbuprofenDRUG

Single dose of a novel ibuprofen formulation (equal to 400mg ibuprofen)

A
PlaceboDRUG

Single dose of a placebo

B

Eligibility Criteria

Age12 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects diagnosed with a fever secondary to an uncomplicated acute viral or bacterial infection.
  • Oral temperature measurement from 100 to 104 degrees Fahrenheit.
  • Onset of fever 3 days or less.
  • Otherwise good health.

You may not qualify if:

  • Fever secondary to a chronic underlying medical condition or serious infection.
  • Currently taking antibiotics or antivirals.
  • Currently taking any medication which may interfere with the assessment of fever.
  • Pregnancy or breast-feeding.
  • Any serious medical or psychiatric disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Pfizer Investigational Site

Cypress, California, 90630, United States

Location

Pfizer Investigational Site

Westlake Village, California, 91361, United States

Location

Pfizer Investigational Site

Omaha, Nebraska, 68144, United States

Location

Pfizer Investigational Site

Pittsburgh, Pennsylvania, 15241, United States

Location

Pfizer Investigational Site

Salt Lake City, Utah, 84124, United States

Location

Related Publications (1)

  • Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.

    PMID: 25526232DERIVED

Related Links

MeSH Terms

Conditions

InfectionsFever

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Limitations and Caveats

Definitive conclusion could not be made due to early termination of study, due to low enrollment rate, and small number of enrolled participants.

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2009

First Posted

December 18, 2009

Study Start

January 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 21, 2012

Results First Posted

August 21, 2012

Record last verified: 2012-07

Locations

US(5)