Placebo and Active Controlled, Double Dummy Study to Comp... | NCT01464983

Studies
Placebo and Active Controlled, Double Dummy Study to Compare Efficacy of Aspirin and Ibuprofen in Treatment of Episodic Tension-type Headache

NCT01464983

Sponsor

Bayer

Status

Completed

Last Update Posted

Dec 25, 2014Estimated

Enrollment

1,115Actual

Phase

Phase 4

Conditions

Headache
Tension-Type Headache
Tension-Type Headache (Episodic)

Interventions

Acetylsalicylic acid (Aspirin, BAYE4465)
Acetylsalicylic acid (Aspirin, BAYE4465)
Ibuprofen
Ibuprofen
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Aug 2004Actual

First Submitted Date

May 17, 2011

First Submission Date that Met QC Criteria

Nov 2, 2011

First Posted Date

Nov 4, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 23, 2014

Last Update Posted Date

Dec 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the efficacy and tolerability of 500 mg and 1000 mg Aspirin® (study medication) by comparing it to placebo (the control group without active substance) or 200 mg or 400 mg Ibuprofen (study medication) in treating the symptoms of episodic tension-type headache. The study is designed to develop a treatment method against episodic tension-type headache which will have more advantages for patients than the methods that are currently available.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,115Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Arm 1	Active Comparator	Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Arm 2	Experimental	Drug: Acetylsalicylic acid (Aspirin, BAYE4465)
Arm 3	Active Comparator	Drug: Ibuprofen
Arm 4	Active Comparator	Drug: Ibuprofen
Arm 5	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Acetylsalicylic acid (Aspirin, BAYE4465)	Drug	Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication		2 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Headache pain relief measured serially on a categorical scale		Until 4 hours post dose
Measuring the functional ability on conducting everydays activity on a 4 point categorical scale		2 and 24 hours post dose

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ambulatory male or female, 18 to 65 years of age
Normal blood pressure
Patients suffering from episodic tension-type headache
Headache lasting from 30 minutes to 7 days
Headache had at least two of the following characteristics:

Bilateral location. Pressing/tightening (non-pulsating). Mild or moderate intensity. Not aggravated by routine physical activity such as walking or climbing stairs.

- Both of the following: No nausea or vomiting. No more than one of photophobia or phonophobia.

Exclusion Criteria:

Other headaches, including migraine, that required medical treatment
Hypersensitivity to acetylsalicylic acid, salicylates, ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs)
Serious physical illness especially uncontrolled disorders of kidney, liver, lung, heart or brain function, neurological disorders or severe chronic or terminal disease
Mental illness, including depression
Needed or were using or likely to need or use any of the prohibited concomitant medications: antidepressants, oxicams
Pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception
Participating in any other clinical study or had done within the previous 4 weeks
Had been previously enrolled in this study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Reading	Berkshire	RG2 7AG	United Kingdom

ID	Term
D006261	Headache
D018781	Tension-Type Headache
D012008	Recurrence

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020969	Disease Attributes
D010335	Pathologic Processes

ID	Term
D012459	Salicylates
D062385	Hydroxybenzoates
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids

ID	Term
D001241	Aspirin
D007052	Ibuprofen