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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842633
• Other study ID #: 202172
• Secondary ID: RH01649
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2013
• Last updated: April 11, 2016
• Start date: April 2013
• Est. completion date: March 2015

Study information

• Verified date: April 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Paracetamol and Caffeine
Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine
• Ibuprofen
Caplets containing 200 mg of ibuprofen

Other:
• Placebo
Matching placebo caplets

Locations

Country	Name	City	State
United States	PAREXEL International, LLC	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of Pain Intensity Difference (SPID) of Treatment and Placebo	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.	4 hours post dose	No
Secondary	Sum of Pain Intensity Difference (SPID) of Other Treatments	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.	1, 2, and 3 hours post dose	No
Secondary	Number of Participants With Perceptible Pain Relief		Baseline up to 4 hours	No
Secondary	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.	Baseline up to 4 hours	No
Secondary	Number of Participants With Meaningful Pain Relief		Baseline up to 4 hours	Yes
Secondary	Time to Meaningful Headache Relief	Time to meaningful headache relief was assessed as time when participants reported a PRS = 2.	Baseline up to 4 hours	No
Secondary	Total Pain Relief (TOTPAR)	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.	1, 2, 3 and 4 hour post dose	No
Secondary	Area Under the Time-Response Curve for Change in Headache Intensity and Headache Relief (SPRID)	SPRID was measured as sum of TOTPAR and SPID.	1, 2, 3 and 4 hour post dose	No
Secondary	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).	4 hours	No
Secondary	Rate of Rescue Medication	Proportion of participants that took rescue medication over the total number of participants for a given treatment group.	4 hours	No
Secondary	Change From Baseline in Headache Pain Intensity	Change from baseline in headache pain intensity was calculated as the change (difference) from baseline pain intensity with pain intensity at each time-point.	10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 180, and 240 min.	No
Secondary	Headache Relief	Headache Relief was measured as PRS over the time.	10 min. 15 min., 20 min., 25 min., 30 min., 40 min., 50 min., 60 min., 90 min., 120 min., 180 min., 240 min.,	No
Secondary	Number of Pain Free Participants	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.	1 hour and 2 hour post dose	No