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

Phase 3TerminatedNCT01842633

GlaxoSmithKline365 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

365

Conditions

Pain

Interventions

Paracetamol and CaffeineDRUG

Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine

IbuprofenDRUG

Caplets containing 200 mg of ibuprofen

PlaceboOTHER

Matching placebo caplets

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

PAREXEL International, LLC

Waltham, Massachusetts, United States

Outcomes

Primary Outcomes

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

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).

Time frame: Up to 4 hours post dose

Secondary Outcomes

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

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).

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

Number of Participants With Perceptible Pain Relief

Time frame: Baseline up to 4 hours

Time to Perceptible Headache Relief

Time to perceptible headache relief was assessed as the time when participants achieve pain relief scores (PRS) more than or equal to 1.

Time frame: Baseline up to 4 hours

Data from ClinicalTrials.gov

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Number of Participants With Meaningful Pain Relief

Time frame: Baseline up to 4 hours

Time to Meaningful Headache Relief

Time to meaningful headache relief was assessed as time when participants reported a PRS ≥ 2.

Time frame: Baseline up to 4 hours

Total Pain Relief (TOTPAR)

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.

Time frame: 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)

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.

Time frame: 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

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).

Time frame: 4 hours

Rate of Rescue Medication

Number of participants that took rescue medication over the total number of participants for a given treatment group

Time frame: 4 hours

Change From Baseline in Headache Pain Intensity

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).

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

Headache Relief

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.

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.,

Number of Pain Free Participants

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 frame: 1 hour and 2 hour post dose

Time to the Use of Rescue Medication.

Time taken by the participants to use the rescue medication

Time frame: Up to 4 hours