Paracetamol With Caffeine to Treat Episodic Tension Type Headache

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Headache, Tension-Type

Treatments: Drug: Experimental paracetamol + caffeine formulation; Drug: Paracetamol marketed formulation; Drug: Placebo; Drug: ibuprofen marketed formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01755702

A2260597

Details and patient eligibility

About

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.

Enrollment: 66 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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66 participants in 4 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Arm 2

Active Comparator group

Description:

paracetamol marketed forumulation

Treatment:

Drug: Paracetamol marketed formulation

Arm 3

Active Comparator group

Description:

ibuprofen marketed formulation

Treatment:

Drug: ibuprofen marketed formulation

Arm 4

Experimental group

Description:

experimental paracetamol + caffeine formulation

Treatment:

Drug: Experimental paracetamol + caffeine formulation