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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01842633
First received: April 25, 2013
Last updated: June 28, 2017
Last verified: September 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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 at 4 Hours [ Time Frame: Up to 4 hours post dose ]
    SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 4 hours post dose. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180, 180-240 minutes. The range of SPID at 4 hours post dose was from -12 to 4". PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).


Secondary Outcome Measures:
  • Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 Hours [ Time Frame: From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose ]

    SPID was calculated as the weighted sum of Pain (Headache) intensity differences at 1, 2 and 3 hours post dose.

    The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60 minutes for SPID at 1 hour post dose. The range of SPID at 1 hour post dose was from -3 to 1. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120 minutes for SPID at 2 hours post dose . The range of SPID at 2 hours post dose was from -6 to 2. The time-intervals used were 0-10, 10-15, 15-20, 20-25, 25-30, 30-40, 40-50, 50-60, 60-90, 90-120, 120-180 minutes for SPID at 3 hours post dose. The range of SPID at 3 hours post dose was from -9 to 3. PID was calculated as difference of pain intensity (PI) at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).


  • Number of Participants With Perceptible Pain Relief [ Time Frame: Baseline up to 4 hours ]
  • Time to Perceptible Headache Relief [ Time Frame: Baseline up to 4 hours ]
    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 ]
  • Time to Meaningful Headache Relief [ Time Frame: Baseline up to 4 hours ]
    Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.

  • Total Pain Relief (TOTPAR) [ Time Frame: From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose ]
    TOTPAR was calculated as the weighted sum of pain relief scores (PRS) at each time point. PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range for TOTPAR for different time points were as follows: from 0 to 4 for TOTPAR at 1 hour post dose, from 0 to 8 for TOTPAR at 2 hours post dose, from 0 to 12 for TOTPAR at 3 hours post dose, and from 0 to 16 for TOTPAR at 4 hours post dose.

  • Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID) [ Time Frame: From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose ]
    SPRID was measured as sum of TOTPAR and SPID. SPID and TOTPAR were calculated as weighted sums of PID and PRS at each measurement time point, respectively. PID at each time point was calculated as difference of PI at baseline (prior to the first dose) with PI at a given time point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache). PRS was assessed on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). The range of SPRID for different time points were as follow: from-3 to 5 for SPRID at 1 hour post dose, from -6 to 10 for SPRID at 2 hours post dose, from -9 to 15 for SPRID at 3 hours post dose, and from -12 to 20 for SPRID at 4 hours post dose.

  • Global Evaluation of Response to Treatment [ Time Frame: 4 hours ]
    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 ]
    Number 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: At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min. ]
    Change from baseline in headache pain intensity was calculated as the change (difference) from baseline PI with PI at each time-point. PI was assessed on a 4-point scale (0-no headache, 1-mild headache, 2-moderate headache, 3-severe headache).

  • Headache Relief [ Time Frame: At 10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min., ]
    The participant assessed headache relief of each treated qualifying headache at 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 minutes post treatment on a 5-point scale (0-no relief, 1-a little relief, 2-some relief, 3-a lot of relief, and 4-complete relief). higher headache relief score indicates better outcome.

  • Number of Pain Free Participants [ Time Frame: 1 hour and 2 hour post dose ]
    Number of participants with complete relief was calculated as the number of participants who reported PRS = 4-complete relief at 1 hour and 2 hours post dose.

  • Time to the Use of Rescue Medication. [ Time Frame: Up to 4 hours ]
    Time taken by the participants to use the rescue medication


Enrollment: 365
Study Start Date: April 1, 2013
Study Completion Date: March 31, 2015
Primary Completion Date: March 1, 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   (Adult)
Sexes Eligible for Study:   All
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 ( Other Identifier: GSK )
Study First Received: April 25, 2013
Results First Received: June 2, 2016
Last Updated: June 28, 2017

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

ClinicalTrials.gov processed this record on August 18, 2017