Paracetamol With Caffeine to Treat Episodic Tension Type Headache

Headache, Tension-Type Clinical Trial

Official title:

A Study to Assess the Efficacy of Paracetamol Taken in Combination With Caffeine for the Treatment of Episodic Tension Type Headache

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01755702
• Other study ID #: A2260597
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: June 23, 2011
• Last updated: March 12, 2015
• Start date: July 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of episodic tension-type headache consistent with all of the following:

1. number of days with the condition is historically greater than or equal to two per month

2. onset of condition was greater than or equal to 12 months from Visit 1

3. age of onset was < 50 years

4. severity of headaches is historically at least moderate

5. duration of headaches is historically greater than or equal to four hours, if untreated

6. number of headache episodes was greater than or equal to 4 and less than or equal to 10 during each of the three months immediately prior to Visit 1

7. treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours

Exclusion Criteria:

• Subject has chronic tension type headache, which is defined as headache on more than 15 days per month for 3 months.

• If a migraine sufferer,subject averages more than one episode per month, is incapable of differentiating between tension-type headaches and migraine headaches, and/or requires regular or prophylactic use of migraine medications

Study Design

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

Related Conditions & MeSH terms

• Headache
• Headache, Tension-Type
• Tension-Type Headache

Intervention

Drug:
• Placebo
Placebo
• Experimental paracetamol + caffeine formulation
experimental paracetamol + caffeine formulation
• ibuprofen marketed formulation
ibuprofen marketed formulation
• Paracetamol marketed formulation
Paracetamol marketed formulation

Locations

Country	Name	City	State
United States	Biomedical Research Alliance of New York LLC	Lake Success	New York
United States	Elkind Headache Center	Mount Vernon	New York
United States	University Clinical Research, Inc.	Pembroke Pines	Florida
United States	Jefferson Headache Center	Philadelphia	Pennsylvania
United States	International Research Service, Inc.	Port Chester	New York
United States	Springfield Neurology Associates	Springfield	Massachusetts
United States	MedVadis Research Corporation	Wellesley Hills	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to First Perceptible Headache Relief	Time to first perceptible pain relief, calculated as time when partcipant selected 'a little' pain relief in the electronic pad minus the time of treatment. If this time was not available in the electronic pad then the earliest time corresponding to a pain relief score 1 or greater was recorded as time to 'a little' pain relief.	Baseline to 6 hours	No
Secondary	Headache Relief Scores	Pain relief scores were measured on a scale from 0-4: 0- No pain relief; 1- Perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief and 4- Complete relief.	Baseline to 4 hours	No
Secondary	Total Pain Relief (TOTPAR)	TOTPAR was calculated as sum of the products of pain relief score at time interval at 0-60 minutes, 60-90 minutes, 90-120 minutes and 120-240 minutes. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.; It was calculated using the following formula.; TOTPAR t = S(Rt x (time t - time t-1)), where Rt = pain relief score at time t; time t = time t in hours; time t-1 = time at previous time-point.	Baseline to 4 hours	No
Secondary	Sum of Pain Intensity Difference (SPID)	Sum of pain intensity difference (SPID) at 60, 90, 120 and 240 minutes - calculated as the sum of headache intensity differences between the baseline pain intensity score and pain intensity score at each timepoint.; Pain intensity was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.; It was calculated using the following formula; SPID t = SPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity.	Baseline to 4 hours	No
Secondary	Sum of TOTPAR and SPID (SPRID)	Area under the time-response curve for change in headache intensity and headache relief (SPRID) at 60, 90, 120 and 240 minutes, was calculated as sum of TOTPAR and SPID: SPRIDt = TOTPARt + SPIDt; TOTPAR was calculated as sum of the products of pain relief score. Participants were asked to choose a number on a scale of 0 to 4, where, 0- No pain relief; 1- A little or perceptible pain relief; 2- Meaningful pain relief; 3- A lot of relief; 4- Complete relief. The mean PRS scores were calculated on the basis of participant's response based on the above score.; SPID was calculated as the sum of headache intensity differences between baseline and at each time point. It was measured by numerical rating scale which is horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.	Baseline to 4 hours	No
Secondary	Time to Rescue Medication	Time to rescue medication was evaluated.	Baseline to 6 hours post dose	No
Secondary	Number of Participants With Complete Headache Relief	Number of headaches resolved at 1 and 2 hours before any rescue medication was calculated as number of participants with complete pain relief and headache severity of 'no headache' over total number of participants. These calculations were based on one headache per treatment per subject.	Baseline to 2 hours	No
Secondary	Headache Severity	Headache severity (scores) at 15, 30, 45, 60, 90, 120, and 240 minutes were calculated as change (difference) from baseline of pain intensity at each time point.; Pain intensity was measured by numerical rating scale which is a horizontal line with a scale from 0-10, where 0 represents no pain and 10 represents the worst possible pain.	Baseline to 4 hours	No
Secondary	Patients Global Assessment in Response to Treatment	Patients Global Assessment in Response to Treatment was assessed by a score in a scale from 0-4: 0- Poor; 1- Fair; 2- Good; 3- Very Good and 4- Excellent.	Baseline to 8 weeks	No