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: March 12, 2015
Last verified: November 2014
  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:
  • Time to First Perceptible Headache Relief [ Time Frame: Baseline to 6 hours ] [ Designated as safety issue: No ]
    Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief.


Secondary Outcome Measures:
  • Headache Relief Scores [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]
    Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.

  • Total Pain Relief (TOTPAR) [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]

    TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.

    It was calculated using the following formula.

    TOTPAR t = Σ(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point.


  • Sum of Pain Intensity Difference (SPID) [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]

    Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes - calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint.

    Pain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.

    It was calculated using the following formula; SPID t = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity.


  • Sum of TOTPAR and SPID (SPRID) [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]

    Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID:

    SPRIDt = TOTPARt + SPIDt

    TOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.

    SPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.


  • Time to Rescue Medication [ Time Frame: Baseline to 6 hours post dose ] [ Designated as safety issue: No ]
    Time to rescue medication was evaluated.

  • Number of Participants With Complete Headache Relief [ Time Frame: Baseline to 2 hours ] [ Designated as safety issue: No ]
    Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of 'no headache' over total number of participants. These calculations were based on one headache per treatment per subject.

  • Headache Severity [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]

    Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point.

    Pain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.


  • Patients Global Assessment in Response to Treatment [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]
    Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.


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
Results First Received: January 16, 2014
Last Updated: March 12, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by GlaxoSmithKline:
caffeine
paracetamol
tension headache

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

ClinicalTrials.gov processed this record on July 29, 2015