Paracetamol With Caffeine to Treat Episodic Tension Type Headache

This study has been terminated.
(Study was terminated due to unforeseen difficulties with subject recruitment. No safety issues were identified in the study with this new formulation.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01755702
First received: June 23, 2011
Last updated: January 24, 2013
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Headache, Tension-Type
Drug: Placebo
Drug: Experimental paracetamol + caffeine formulation
Drug: ibuprofen marketed formulation
Drug: Paracetamol marketed formulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Assess the Efficacy of Paracetamol Taken in Combination With Caffeine for the Treatment of Episodic Tension Type Headache

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • headache relief [ Time Frame: Day 56 (Visit 3) ] [ Designated as safety issue: No ]
    compare the efficacy of the rapidly-absorbed paracetamol + caffeine (RAPC) formula versus placebo in terms speed of onset as measured by time to perceptible first (i.e., "a little") using the pain relief/severity assessments diary cards.


Enrollment: 66
Study Start Date: July 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1
Placebo
Drug: Placebo
Placebo
Active Comparator: Arm 2
paracetamol marketed forumulation
Drug: Paracetamol marketed formulation
Paracetamol marketed formulation
Active Comparator: Arm 3
ibuprofen marketed formulation
Drug: ibuprofen marketed formulation
ibuprofen marketed formulation
Experimental: Arm 4
experimental paracetamol + caffeine formulation
Drug: Experimental paracetamol + caffeine formulation
experimental paracetamol + caffeine formulation

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01755702

Locations
United States, Florida
University Clinical Research, Inc.
Pembroke Pines, Florida, United States, 33024
United States, Massachusetts
Springfield Neurology Associates
Springfield, Massachusetts, United States, 01104
MedVadis Research Corporation
Wellesley Hills, Massachusetts, United States, 02481
United States, New York
Biomedical Research Alliance of New York LLC
Lake Success, New York, United States, 11042
Elkind Headache Center
Mount Vernon, New York, United States, 10550
International Research Service, Inc.
Port Chester, New York, United States, 10573
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01755702     History of Changes
Other Study ID Numbers: A2260597
Study First Received: June 23, 2011
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
caffeine
tension headache
paracetamol

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Acetaminophen
Ibuprofen
Caffeine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Central Nervous System Stimulants
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 18, 2014