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TREXIMET® Versus Butalbital-containing Combination Medications for the Acute Treatment of Migraine in Adults

NCT ID: NCT00573170

Last Updated: 2010-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

375 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-08-31

Brief Summary

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Study TRX109011/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 (Studies 1 and 2 of 2)

Detailed Description

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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. These two replicate studies were amended while ongoing to allow for the reporting of pooled data only.

Conditions

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Migraine Disorders Migraine, Acute

Keywords

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Migraine, acute Migraine Butalbital-containing Combination Medication (BCM) Naproxen sodium Sumatriptan succinate TREXIMET®

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TPB

TREXIMET® (Attack 1), placebo (Attack 2), BCM (Attack 3)

Group Type OTHER

TREXIMET®

Intervention Type DRUG

Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg)

Butalbital-containing Combination Medications (BCM)

Intervention Type DRUG

butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\]

placebo

Intervention Type DRUG

placebo

TBP

TREXIMET® (Attack 1), BCM (Attack 2), placebo (Attack 3)

Group Type OTHER

TREXIMET®

Intervention Type DRUG

Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg)

Butalbital-containing Combination Medications (BCM)

Intervention Type DRUG

butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\]

placebo

Intervention Type DRUG

placebo

BTP

BCM (Attack 1), TREXIMET® (Attack 2), placebo (Attack 3)

Group Type OTHER

TREXIMET®

Intervention Type DRUG

Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg)

Butalbital-containing Combination Medications (BCM)

Intervention Type DRUG

butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\]

placebo

Intervention Type DRUG

placebo

BPT

BCM (Attack 1), placebo (Attack 2), TREXIMET® (Attack 3)

Group Type OTHER

TREXIMET®

Intervention Type DRUG

Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg)

Butalbital-containing Combination Medications (BCM)

Intervention Type DRUG

butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\]

placebo

Intervention Type DRUG

placebo

PTB

placebo (Attack 1), TREXIMET® (Attack 2), BCM (Attack 3)

Group Type OTHER

TREXIMET®

Intervention Type DRUG

Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg)

Butalbital-containing Combination Medications (BCM)

Intervention Type DRUG

butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\]

placebo

Intervention Type DRUG

placebo

PBT

placebo (Attack 1), BCM (Attack 2), TREXIMET® (Attack 3)

Group Type OTHER

TREXIMET®

Intervention Type DRUG

Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg)

Butalbital-containing Combination Medications (BCM)

Intervention Type DRUG

butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\]

placebo

Intervention Type DRUG

placebo

Interventions

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TREXIMET®

Sumatriptan + Naproxen Sodium (fixed dose combination tablet of sumatriptan succinate \[equivalent to sumatriptan 85mg\] and naproxen sodium 500mg)

Intervention Type DRUG

Butalbital-containing Combination Medications (BCM)

butalbital-containing combination medication (BCM; acetaminophen 325mg, caffeine 40mg, and butalbital 50mg) \[currently marketed as Fioricet\]

Intervention Type DRUG

placebo

placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males and females aged 18 to 65 years. Female subjects are eligible for participation if they are either of non-childbearing potential (not capable of becoming pregnant) OR of childbearing potential having a negative urine pregnancy test at screening, and using contraception if sexually active. If using oral contraceptives, the subjects should be on a stable regimen of oral contraceptives (\>/= 2 months).

Eligible subjects must:

* have migraine with or without aura (2004 ICHD-II criteria) and must have had at least 2 attacks per month meeting these criteria in the three months prior to screening.
* have documented use of Butalbital-containing Combination Medication (MCM) to have treated at least one migraine.
* be able to understand how to complete the cognitive assessments and all other questionnaires programmed in an electronic diary.
* be willing and able to provide written informed consent.

Exclusion Criteria

A subject is not eligible if they have:

* \>8 migraines or \>/= 15 headache days per month in total, or has retinal, basilar, or hemiplegic migraine, or secondary headaches.
* taken \>350mg/day of butalbital and/or other barbiturates on an equivalent dose basis, on average, over the 30 days prior to screening.
* is likely to have unrecognized cardiovascular or cerebrovascular disease (based on history or risk factors).
* blood pressure \>/= 140/90mmHg in 2 out of 3 BP measurements or is taking any angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker.
* history of congenital heart disease, cardiac arrhythmias requiring medication, or a clinical significant electrocardiogram abnormality.
* evidence or history of any ischemic vascular disease including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or signs/symptoms consistent with these.
* evidence or history of central nervous system pathology including stroke and/or transient ischemic attacks (TIAs), epilepsy or structural brain lesions which lower the convulsive threshold; or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening.
* a history of impaired hepatic or renal function that contraindicates participation in the study.
* hypersensitivity, allergy, intolerance, or contraindication to the use of any triptan, NSAID, aspirin, barbiturates, or acetaminophen (including all sumatriptan and naproxen preparations), has porphyria or has nasal polyps and asthma.
* is currently taking, or has taken in the previous three months, an ergot preparation for migraine prophylaxis; or is taking a migraine or prophylactic medication that is not stabilized (i.e. a change of dose within the last 2 months) for either chronic or intermittent migraine prophylaxis or for a co-morbid condition that is not stabilized.
* a recent history of regular use of opioids (including opioids in combination with butalbital, e.g. Fioricet with codeine) or barbiturates other than butalbital. Regular use is defined as an average of 4 days per month over the last 6 months.
* taken, or plans to take, a monoamine oxidase inhibitor (MAOI), including herbal preparations containing St. John's Wort (Hypericum perforatum), anytime within the 2 weeks prior to screening through 2 weeks post final study treatment.
* history of any bleeding disorder or is currently taking any anti-coagulant or any antiplatelet agent (except low-dose aspirin \</= 325mg/day for cardioprotective reasons).
* evidence or history of any gastrointestinal surgery or GI ulceration or perforation in the past six months, gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease.
* is pregnant, actively trying to become pregnant, breast feeding, or not willing to have pregnancy test performed.
* evidence of alcohol or substance abuse within the last year or any concurrent medical or psychiatric condition which, in the investigator's judgement, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicates participation in this clinical study.
* participated in an investigational drug trial within the previous four weeks or plans to participate in another study at any time during this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK Clinical Disclosure

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Chandler, Arizona, United States

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Gilbert, Arizona, United States

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Litchfield Park, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Little Rock, Arkansas, United States

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Little Rock, Arkansas, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Garden Grove, California, United States

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Irvine, California, United States

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Newport Beach, California, United States

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Northridge, California, United States

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Riverside, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Santa Monica, California, United States

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Sherman Oaks, California, United States

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Walnut Creek, California, United States

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Westlake Village, California, United States

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Colorado Springs, Colorado, United States

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East Hartford, Connecticut, United States

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New Britain, Connecticut, United States

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Clearwater, Florida, United States

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Daytona Beach, Florida, United States

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DeLand, Florida, United States

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Naples, Florida, United States

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Pembroke Pines, Florida, United States

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Plantation, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Atlanta, Georgia, United States

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Rome, Georgia, United States

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Savannah, Georgia, United States

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Suwanee, Georgia, United States

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Chicago, Illinois, United States

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Gurnee, Illinois, United States

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Maywood, Illinois, United States

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Indianapolis, Indiana, United States

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Paducah, Kentucky, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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Biddeford, Maine, United States

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Pikesville, Maryland, United States

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Brockton, Massachusetts, United States

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Springfield, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Kalamazoo, Michigan, United States

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Hattiesburg, Mississippi, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Cherry Hill, New Jersey, United States

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Ridgewood, New Jersey, United States

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Stratford, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Mount Vernon, New York, United States

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New York, New York, United States

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New York, New York, United States

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Orchard Park, New York, United States

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Schenectady, New York, United States

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Syracuse, New York, United States

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The Bronx, New York, United States

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Valley Stream, New York, United States

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Cary, North Carolina, United States

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Charlotte, North Carolina, United States

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Greenville, North Carolina, United States

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Hickory, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Bismarck, North Dakota, United States

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Fargo, North Dakota, United States

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Minot, North Dakota, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Columbus, Ohio, United States

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Dayton, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Greensburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Warwick, Rhode Island, United States

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Beaufort, South Carolina, United States

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Charleston, South Carolina, United States

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Simpsonville, South Carolina, United States

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Rapid City, South Dakota, United States

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Columbia, Tennessee, United States

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Cordova, Tennessee, United States

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Germantown, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Salt Lake City, Utah, United States

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Virginia Beach, Virginia, United States

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Countries

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Puerto Rico United States

References

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Silberstein SD, McCrory DC. Butalbital in the treatment of headache: history, pharmacology, and efficacy. Headache. 2001 Nov-Dec;41(10):953-67. doi: 10.1046/j.1526-4610.2001.01189.x.

Reference Type BACKGROUND
PMID: 11903523 (View on PubMed)

Bigal ME, Rapoport AM, Sheftell FD, Tepper SJ, Lipton RB. Transformed migraine and medication overuse in a tertiary headache centre--clinical characteristics and treatment outcomes. Cephalalgia. 2004 Jun;24(6):483-90. doi: 10.1111/j.1468-2982.2004.00691.x.

Reference Type BACKGROUND
PMID: 15154858 (View on PubMed)

Wenzel RG, Sarvis CA. Do butalbital-containing products have a role in the management of migraine? Pharmacotherapy. 2002 Aug;22(8):1029-35. doi: 10.1592/phco.22.12.1029.33595.

Reference Type BACKGROUND
PMID: 12173787 (View on PubMed)

Derosier F, Sheftell F, Silberstein S, Cady R, Ruoff G, Krishen A, Peykamian M. Sumatriptan-naproxen and butalbital: a double-blind, placebo-controlled crossover study. Headache. 2012 Apr;52(4):530-43. doi: 10.1111/j.1526-4610.2011.02039.x. Epub 2011 Nov 21.

Reference Type DERIVED
PMID: 22103635 (View on PubMed)

Other Identifiers

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TRX109011/TRX109013

Identifier Type: -

Identifier Source: org_study_id

NCT00599157

Identifier Type: -

Identifier Source: nct_alias

NCT01812408

Identifier Type: -

Identifier Source: nct_alias