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

Primary Purpose

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

Status

Completed

Phase

Phase 4

Locations

United Kingdom

Study Type

Interventional

Intervention

Acetylsalicylic acid (Aspirin, BAYE4465)

Ibuprofen

Placebo

About this trial

This is an interventional treatment trial for Headache

Eligibility Criteria

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

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Active Comparator

Experimental

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Description

Outcomes

Primary Outcome Measures

Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication

Secondary Outcome Measures

Headache pain relief measured serially on a categorical scale

Measuring the functional ability on conducting everydays activity on a 4 point categorical scale

Global assessment of pain therapy

Safety - assessment of adverse events

Full Information

NCT ID

NCT01464983

First Posted

May 17, 2011

Last Updated

December 23, 2014

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01464983

Brief Title

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

Official Title

A Multicentre Randomised Parallel-groups Double-blind Double-dummy Single-dose Study to Compare Acetylsalicylic Acid 500 mg and 1,000 mg With Ibuprofen 200 mg and 400 mg and Placebo for Tolerability and Efficacy in the Treatment of Episodic Tension-type Headache

Study Type

Interventional

2. Study Status

Record Verification Date

December 2014

Overall Recruitment Status

Completed

Study Start Date

January 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1115 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Active Comparator

Arm Title

Arm 2

Arm Type

Experimental

Arm Title

Arm 3

Arm Type

Active Comparator

Arm Title

Arm 4

Arm Type

Active Comparator

Arm Title

Arm 5

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Description

Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic acid (Aspirin, BAYE4465)

Intervention Description

Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid

Intervention Type

Drug

Intervention Name(s)

Ibuprofen

Intervention Description

Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose

Primary Outcome Measure Information:

Title

Percentage of subjects with total or meaningful headache relief at 2 hours after intake of study medication

Time Frame

2 hours post dose

Secondary Outcome Measure Information:

Title

Headache pain relief measured serially on a categorical scale

Time Frame

Until 4 hours post dose

Title

Measuring the functional ability on conducting everydays activity on a 4 point categorical scale

Time Frame

2 and 24 hours post dose

Title

Global assessment of pain therapy

Time Frame

24 hours post dose

Title

Safety - assessment of adverse events

Time Frame

Up to 10 weeks after screening

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Reading

State/Province

Berkshire

ZIP/Postal Code

RG2 7AG

Country

United Kingdom

City

Manchester

State/Province

Greater Manchester

ZIP/Postal Code

M15 6SX

Country

United Kingdom

City

Chorley

State/Province

Lancashire

ZIP/Postal Code

PR7 1NY

Country

United Kingdom

City

Wigan

State/Province

Lancashire

ZIP/Postal Code

WN6 9EW

Country

United Kingdom

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L1 9AD

Country

United Kingdom

City

Liverpool

State/Province

Merseyside

ZIP/Postal Code

L22 0LG

Country

United Kingdom

City

Cardiff

State/Province

South Glamorgan

ZIP/Postal Code

CF14 5GJ

Country

United Kingdom

City

Glasgow

State/Province

Strathclyde

ZIP/Postal Code

G81 2DR

Country

United Kingdom

City

Birmingham

State/Province

West Midlands

ZIP/Postal Code

B15 2SQ

Country

United Kingdom

City

Coventry

State/Province

West Midlands

ZIP/Postal Code

CV1 2TZ

Country

United Kingdom

City

Wolverhampton

State/Province

West Midlands

ZIP/Postal Code

WV10 9RU

Country

United Kingdom

12. IPD Sharing Statement

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

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