Paracetamol With Caffeine to Treat Episodic Tension Type Headache

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-03-31

Brief Summary

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This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.

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Detailed Description

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Conditions

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Headache, Tension-Type

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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Arm 1

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Arm 2

paracetamol marketed forumulation

Group Type ACTIVE_COMPARATOR

Paracetamol marketed formulation

Intervention Type DRUG

Paracetamol marketed formulation

Arm 3

ibuprofen marketed formulation

Group Type ACTIVE_COMPARATOR

ibuprofen marketed formulation

Intervention Type DRUG

ibuprofen marketed formulation

Arm 4

experimental paracetamol + caffeine formulation

Group Type EXPERIMENTAL

Experimental paracetamol + caffeine formulation

Intervention Type DRUG

experimental paracetamol + caffeine formulation

Interventions

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Placebo

Intervention Type DRUG

Experimental paracetamol + caffeine formulation

experimental paracetamol + caffeine formulation

Intervention Type DRUG

ibuprofen marketed formulation

Intervention Type DRUG

Paracetamol marketed formulation

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of episodic tension-type headache consistent with all of the following:

1. number of days with the condition is historically greater than or equal to two per month
2. onset of condition was greater than or equal to 12 months from Visit 1
3. age of onset was \< 50 years
4. severity of headaches is historically at least moderate
5. duration of headaches is historically greater than or equal to four hours, if untreated
6. number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1
7. treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours

Exclusion Criteria

* Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.
* If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No