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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01842633
First received: April 25, 2013
Last updated: April 11, 2016
Last verified: April 2016
  Purpose
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
Pain
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 Treatment and Placebo [ Time Frame: 4 hours post dose ] [ Designated as safety issue: No ]
    SPID was calculated as the weighted sum of pain intensity differences at 4 hours post dose. Pain intensity at each time point was calculated as difference of pain intensity at baseline with pain intensity at a given time point. n=number of participants analyzed in respective treatment arm for this outcome measure.


Secondary Outcome Measures:
  • Sum of Pain Intensity Difference (SPID) of Other Treatments [ Time Frame: 1, 2, and 3 hours post dose ] [ Designated as safety issue: No ]
    SPID at each time point was calculated as weighted sum of pain intensity differences at baseline with pain intensity at a given time point. n= number of participants analyzed in respective treatment arm for this outcome measure varies over time.

  • Number of Participants With Perceptible Pain Relief [ Time Frame: Baseline up to 4 hours ] [ Designated as safety issue: No ]
  • Time to Perceptible Headache Relief [ Time Frame: Baseline up to 4 hours ] [ Designated as safety issue: No ]
    Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.

  • Number of Participants With Meaningful Pain Relief [ Time Frame: Baseline up to 4 hours ] [ Designated as safety issue: Yes ]
  • Time to Meaningful Headache Relief [ Time Frame: Baseline up to 4 hours ] [ Designated as safety issue: No ]
    Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.

  • Total Pain Relief (TOTPAR) [ Time Frame: 1, 2, 3 and 4 hour post dose ] [ Designated as safety issue: No ]
    TOTPAR was calculated as the weighted sum of pain relief scores of PRS at each time point with time interval between any two time points being used. n= number of participants analyzed in respective treatment arm for this outcome measure varies over time.

  • Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID) [ Time Frame: 1, 2, 3 and 4 hour post dose ] [ Designated as safety issue: No ]
    SPRID was measured as sum of TOTPAR and SPID.

  • Global Evaluation of Response to Treatment [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Global evaluation of treatment response was 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 participants that took rescue medication over the total number of participants for a given treatment group.

  • Change From Baseline in Headache Pain Intensity [ Time Frame: 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min. ] [ Designated as safety issue: No ]
    Change from baseline in headache pain intensity was calculated as the change (difference) from baseline pain intensity with pain intensity at each time-point.

  • Headache Relief [ Time Frame: 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min., ] [ Designated as safety issue: No ]
    Headache Relief was measured as PRS over the time.

  • Number of Pain Free Participants [ Time Frame: 1 hour and 2 hour post dose ] [ Designated as safety issue: No ]
    Number of participants with complete relief was calculated as the ratio of number of participants that reported PRS = 4 over the total number of participants for a given treatment group.


Enrollment: 365
Study Start Date: April 2013
Study Completion Date: March 2015
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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01842633

Locations
United States, Massachusetts
PAREXEL International, LLC
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01842633     History of Changes
Other Study ID Numbers: 202172  RH01649 
Study First Received: April 25, 2013
Last Updated: April 11, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acetaminophen
Caffeine
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Central Nervous System Stimulants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Phosphodiesterase Inhibitors
Physiological Effects of Drugs
Purinergic Agents
Purinergic Antagonists
Purinergic P1 Receptor Antagonists
Sensory System Agents

ClinicalTrials.gov processed this record on May 24, 2016