Protocol Summary for TRX109013
| Protocol Id: | TRX109013 |
| Secondary Ids: |
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| Title: | A Crossover, Randomized, Double-blind, Double-dummy, Placebo-controlled Study to Evaluate the Efficacy of TREXIMET®/Sumatriptan + Naproxen Sodium vs. Butalbital-containing Combination Medications for the Acute Treatment of Migraine when administered during Moderate-Severe Migraine Pain, 2 of 2 |
| Phase: | phase 3 |
| Acronym: | |
| FDA Regulated Intervention?: | Yes |
| Section 801 Clinical Trial?: | Yes |
| Delayed Posting: | No |
| IND/IDE Protocol?: | yes |
| IND/IDE Grantor: | CDER |
| IND/IDE Number: | 68,436 |
| IND/IDE Serial Number: | 072 |
| Has Expanded Access?: | no |
| Study Type: | Interventional |
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| Brief Summary: | Study TRX109013, A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of TREXIMET® (Sumatriptan + Naproxen Sodium) versus Butalbital-Containing Combination Medications (BCM) for the Acute Treatment of Migraine When Administered During the Moderate-Severe Pain Phase of the Migraine (Study 2 of 2) |
| Detailed Description: | This study is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, crossover, three-attack, outpatient study in which TREXIMET® will be compared to a butalbital-containing Combination Medication (BCM: acetaminophen 325mg, caffeine 40mg, and butalbital 50mg [Fioricet]) for the acute treatment of migraine headaches. Subjects will be randomized to one of 6 possible treatment sequences (TPB, TBP, BTP, BPT, PTB, PBT where T = TREXIMET®, P = Placebo, B = Butalbital-containing Combination Medication). Subjects will treat each of the 3 migraine attacks when pain is moderate to severe. The study will include 4 visits: (1) a Screening Visit at study entry, (2) a Drug Screen Visit, (3) a Randomization Visit, and (4) a Final Visit. The Final Visit occurs either (A) upon withdrawal or (B) after treatment of 3 migraine attacks. The primary objective is to evaluate the efficacy of TREXIMET® versus BCM for the acute treatment of moderate/severe migraine. |
| Record Verification Date: | |
| Status: | Completed |
| Why Study Stopped: | |
| Study Start Date: | December 2007 |
| Study Completion Date: | July 2009 |
| Study Completion Date Type: | Actual |
| Primary Completion Date: | July 2009 |
| Primary Completion Date Type: | Actual |
| Primary Purpose: | treatment |
| Allocation: | Randomized |
| Masking: | Double Blind |
| Masked Subject: | yes |
| Masked Caregiver: | no |
| Masked Investigator: | yes |
| Masked Assessor: | no |
| Study Design (Assignment): | Crossover Assignment |
| Study Classification (Endpoint): | Safety/Efficacy Study |
| Primary Outcomes: |
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| Eligibility Criteria: |
Click to view inclusion/exclusion criteria
Inclusion Criteria: |
| Gender: | Both |
| Minimum Age: | 18 Year |
| Maximum Age: | 65 Year |
| Enrollment: | 220 |
| Enrollment Type: | Actual |
| Healthy Volunteers?: | none |
| Central Contact: | Call Center |
| Central Contact Phone: | 877-379-3718 |
| Central Contact Email: | GSKClinicalSupportHD@gsk.com |
| Backup Central Contact: | |
| Backup Central Contact Phone: | |
| Backup Central Contact Email: | |
| Overall Study Official: | GSK Clinical Trials |
| Overall Study Official Affiliation: | GlaxoSmithKline |
| Overall Study Official Role: | Study Director |
| Responsible Party Name/Official Title: | Cheri Hudson; Clinical Disclosure Advisor |
| Responsible Party Organization: | GSK Clinical Disclosure |
| Location and Contact Information: | No locations currently recruiting for this study. |

Click to view inclusion/exclusion criteria