Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: April 25, 2013
Last updated: December 11, 2014
Last verified: December 2014
The purpose of this multi-center study is to assess the efficacy of headache relief of new paracetamol/caffeine formulation compared to placebo and ibuprofen in episodic tension-type headache (ETTH).

Condition Intervention Phase
Drug: Paracetamol and Caffeine
Drug: Ibuprofen
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Assess Efficacy Over Placebo and Speed of Onset of Pain Relief of New Paracetamol and Caffeine Tablets as Compared to Ibuprofen in Episodic Tension Type Headache

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Sum of pain intensity difference (SPID) of experimental formulation vs placebo [ Time Frame: Baseline to 4 hours post dose ] [ Designated as safety issue: No ]
    SPID to be calculated as the sum of headache intensity differences at 4 hours post-dose. Pain intensity at each time point will be calculated as difference of pain intensity at baseline with pain intensity at a given time point.

Secondary Outcome Measures:
  • SPID of other treatments [ Time Frame: Baseline, 1, 2, 3 and 4 hours post dose ] [ Designated as safety issue: No ]
    Pain intensity at each time point will be calculated as difference of pain intensity at baseline with pain intensity at a given time point.

  • Time to perceptible headache relief [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]
    This endpoint will be assessed as time when participants achieve pain relief scores (PRS) more than or equal to 1.

  • Time to meaningful headache relief [ Time Frame: Baseline to 4 hours ] [ Designated as safety issue: No ]
    This endpoint will be assessed as time when subjects reported a PRS ≥ 2.

  • Total pain relief (TOTPAR) [ Time Frame: 1, 2, 3 and 4 hour post dose ] [ Designated as safety issue: No ]
    TOTPAR will be sum of products of PRS at each time point with time interval between any two time points being used.

  • Sum of TOTPAR and SPID (SPRID) [ Time Frame: 1, 2, 3 and 4 hour post dose ] [ Designated as safety issue: No ]
    Area under the time-response curve for change in headache intensity and headache relief.

  • Global Evaluation of Response to Treatment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Global evaluation of treatment response is to be measured by a score in a scale from: 0-very poor, 1-poor, 2-neutral [neither poor nor good], 3-good, or 4-very good).

  • Rate of rescue medication [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Proportion of subjects that took rescue medication over the total number of subjects for a given treatment group.

  • Time to rescue medication [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Median time taken by participants who will opt for rescue medication to be determined.

Estimated Enrollment: 300
Study Start Date: April 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracetamol/ Caffeine Caplets
Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered
Drug: Paracetamol and Caffeine
Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine
Active Comparator: Ibuprofen Caplets
Two ibuprofen caplets plus two placebo caplets to be administered
Drug: Ibuprofen
Caplets containing 200 mg of ibuprofen
Placebo Comparator: Placebo Caplets
Four placebo caplets to be administered
Other: Placebo
Matching placebo caplets


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Participants in good general health, and with diagnosis of ETTH with following conditions:

    1. number of days with the condition is historically greater than or equal to two per month;
    2. severity of headaches is historically at least moderate;
    3. duration of headaches is historically more than or equal to 4 hours, if untreated.

      Exclusion Criteria:

  • Participant with known or suspected hypersensitivity, allergy, intolerance or contraindication to the use of any of the study medications
  • Participant has chronic tension type headache, psychiatric disease or a significant cognitive disorder, or any chronic pain disorder.
  • Participant currently taking or has taken medications or herbal supplements within the three months that are likely to interfere with the validity of subject-rated assessments.
  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 identifier: NCT01842633

Contact: US GSK Clinical Trials Call Center 877-379-3718

United States, Massachusetts
PAREXEL International, LLC Recruiting
Waltham, Massachusetts, United States, 02451
Contact: US GSK Clinical Trials Call Center    877-379-3718   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466   
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline Identifier: NCT01842633     History of Changes
Other Study ID Numbers: 202172  RH01649 
Study First Received: April 25, 2013
Last Updated: December 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
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
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Sensory System Agents
Therapeutic Uses processed this record on February 11, 2016