Last updated: 11/07/2018 12:28:12

Clinical study to evaluate efficacy of new paracetamol formulation compared to ibuprofen in headache

GSK study ID
202172
See study documents
Clinicaltrials.gov ID
NCT01842633
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 hours

Timeframe: Up to 4 hours post dose

Secondary outcomes:

Sum of Pain Intensity Difference (SPID) at 1, 2 and 3 hours

Timeframe: From (Baseline) 0 to 1 hour, 0 to 2 hours, and 0 to 3 hours post dose

Number of Participants With Perceptible Pain Relief

Timeframe: Baseline up to 4 hours

Time to Perceptible Headache Relief

Timeframe: Baseline up to 4 hours

Number of Participants With Meaningful Pain Relief

Timeframe: Baseline up to 4 hours

Time to Meaningful Headache Relief

Timeframe: Baseline up to 4 hours

Total Pain Relief (TOTPAR)

Timeframe: From (Baseline) 0 to 1, from 0 to 2, from 0 to 3 and from 0 to 4 hour post dose

Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)

Timeframe: From (Baseline) 0 to 1 hour, 0 to 2 hours, 0 to 3 hours and 0 to 4 hours post dose

Global Evaluation of Response to Treatment

Timeframe: 4 hours

Rate of Rescue Medication

Timeframe: 4 hours

Change From Baseline in Headache Pain Intensity

Timeframe: At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.

Headache Relief

Timeframe: 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.,

Number of Pain Free Participants

Timeframe: 1 hour and 2 hour post dose

Time to the use of rescue medication.

Timeframe: Up to 4 hours

Interventions:
  • Drug: Paracetamol and Caffeine
  • Drug: Ibuprofen
  • Other: Placebo
    • Enrollment:
    365
    Primary completion date:
    2015-31-03
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    26 June 2017 Volume 2017:9 Pages 41—57 DOI https://doi.org/10.2147/OAJCT.S133629
    Medical condition
    Pain
    Product
    AH14925, ibuprofen, paracetamol, paracetamol/caffeine
    Collaborators
    Not applicable
    Study date(s)
    April 2013 to March 2015
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    Yes
    • Participants in good general health, and with diagnosis of ETTH with following conditions:
    • a. number of days with the condition is historically greater than or equal to two per month;
    • 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.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Participants in good general health, and with diagnosis of ETTH with following conditions: a. number of days with the condition is historically greater than or equal to two per month; b. severity of headaches is historically at least moderate; c. 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    PAREXEL International, LLC
    Waltham, MA, United States, 02451
    Status
    Study Complete
    Contact us

    Study documents

    Statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Other
    Actual primary completion date
    2015-31-03
    Actual study completion date
    2015-31-03

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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