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Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

Primary Purpose

Migraine Disorders

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
sumatriptan succinate/naproxen sodium
placebo
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine Disorders focused on measuring consistency of response, migraine, satisfaction, early intervention

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month. Typically experiences moderate to severe migraine pain preceded by a mild pain phase. Differentiate between mild migraine pain and other headache types. Women of childbearing potential must be on adequate contraception. Exclusion Criteria: Pregnant and/or nursing mother. History of cardiovascular disease. Uncontrolled hypertension. Basilar or Hemiplegic migraine. History of stroke or transient ischemic attacks (TIA). History of epilepsy or treated with anti-epileptics within past 5 years. Impaired hepatic or renal function. History of gastrointestinal bleeding or ulceration. Allergy or hypersensitivity to Aspirin or any other NSAID. Allergy or hypersensitivity to triptans. Participated in an investigational drug trial in the previous 4 weeks.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

arm 1

arm 2

Arm Description

Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA

placebo to match

Outcomes

Primary Outcome Measures

Score on a 4 pt migraine pain scale for multiple migraine attacks

Secondary Outcome Measures

Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability

Full Information

First Posted
October 14, 2005
Last Updated
October 24, 2016
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00240617
Brief Title
Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks
Official Title
A Randomized, Double-blind, Multi-center, Placebo-controlled, Cross-over Study to Determine the Consistency of Response for Trexima* (Sumatriptan 85mg/Naproxen Sodium 500mg) Administered During the Mild Pain Phase for the Acute Treatment of Multiple Migraine Attacks (*Treximet)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Disorders
Keywords
consistency of response, migraine, satisfaction, early intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
623 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arm 1
Arm Type
Active Comparator
Arm Description
Treximet (sumatriptan/naproxen sodium) formerly known as TREXIMA
Arm Title
arm 2
Arm Type
Placebo Comparator
Arm Description
placebo to match
Intervention Type
Drug
Intervention Name(s)
sumatriptan succinate/naproxen sodium
Intervention Description
comparator
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo to match
Primary Outcome Measure Information:
Title
Score on a 4 pt migraine pain scale for multiple migraine attacks
Time Frame
2 to 24 hours
Secondary Outcome Measure Information:
Title
Within patient consistency of response, freedom from all migraine pain and symptoms, satisfaction, presence or absence of neck pain/discomfort, sinus pain/pressure, recurrence of head pain, safety and tolerability
Time Frame
2 to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month. Typically experiences moderate to severe migraine pain preceded by a mild pain phase. Differentiate between mild migraine pain and other headache types. Women of childbearing potential must be on adequate contraception. Exclusion Criteria: Pregnant and/or nursing mother. History of cardiovascular disease. Uncontrolled hypertension. Basilar or Hemiplegic migraine. History of stroke or transient ischemic attacks (TIA). History of epilepsy or treated with anti-epileptics within past 5 years. Impaired hepatic or renal function. History of gastrointestinal bleeding or ulceration. Allergy or hypersensitivity to Aspirin or any other NSAID. Allergy or hypersensitivity to triptans. Participated in an investigational drug trial in the previous 4 weeks.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Facility Name
GSK Investigational Site
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
Facility Name
GSK Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85201
Country
United States
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
GSK Investigational Site
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
GSK Investigational Site
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
GSK Investigational Site
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
GSK Investigational Site
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
GSK Investigational Site
City
Avon
State/Province
Connecticut
ZIP/Postal Code
06001
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
GSK Investigational Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
GSK Investigational Site
City
South Daytona
State/Province
Florida
ZIP/Postal Code
32119
Country
United States
Facility Name
GSK Investigational Site
City
Stuart
State/Province
Florida
ZIP/Postal Code
34996
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
GSK Investigational Site
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
GSK Investigational Site
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
GSK Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47712
Country
United States
Facility Name
GSK Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
GSK Investigational Site
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
GSK Investigational Site
City
St. Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
GSK Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Moorestown
State/Province
New Jersey
ZIP/Postal Code
08057
Country
United States
Facility Name
GSK Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
GSK Investigational Site
City
Albany
State/Province
New York
ZIP/Postal Code
12206
Country
United States
Facility Name
GSK Investigational Site
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
GSK Investigational Site
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
GSK Investigational Site
City
Valley Stream
State/Province
New York
ZIP/Postal Code
11580
Country
United States
Facility Name
GSK Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
GSK Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
GSK Investigational Site
City
Concinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
GSK Investigational Site
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Facility Name
GSK Investigational Site
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
GSK Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
GSK Investigational Site
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19114
Country
United States
Facility Name
GSK Investigational Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
GSK Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
GSK Investigational Site
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
GSK Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
GSK Investigational Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
GSK Investigational Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
20855373
Citation
Torgovnick J, Sethi NK, Arsura E. Consistency of response to sumatriptan/naproxen sodium in a placebo-controlled cross-over study. Cephalalgia. 2010 Oct;30(10):1277; author reply 1277-9. doi: 10.1177/0333102409352810. Epub 2010 May 13. No abstract available.
Results Reference
result
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX103635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX103635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX103635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX103635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX103635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX103635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
TRX103635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks

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