Clinical trial NCT01842633: Clinical Study to Evaluate Efficacy of New Paracetamol Formulation Compared to Ibuprofen in Headache
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2013-04-29
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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.

Primary outcomes:
measure: Sum of Pain Intensity Difference (SPID) of Treatment and Placebo at 4 Hours
timeFrame: Up to 4 hours post dose
Secondary outcomes:
measure: 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
measure: Number of Participants With Perceptible Pain Relief
timeFrame: Baseline up to 4 hours
measure: Time to Perceptible Headache Relief
timeFrame: Baseline up to 4 hours
measure: Number of Participants With Meaningful Pain Relief
timeFrame: Baseline up to 4 hours
measure: Time to Meaningful Headache Relief
timeFrame: Baseline up to 4 hours
measure: 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
measure: 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
measure: Global Evaluation of Response to Treatment
timeFrame: 4 hours
measure: Rate of Rescue Medication
timeFrame: 4 hours
measure: Change From Baseline in Headache Pain Intensity
timeFrame: At 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.
measure: 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.,
measure: Number of Pain Free Participants
timeFrame: 1 hour and 2 hour post dose
measure: Time to the Use of Rescue Medication.
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Waltham
country: United States
facility: PAREXEL International, LLC
state: Massachusetts
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: