Paracetamol With Caffeine to Treat Episodic Tension Type Headache

Phase 2

Terminated

Conditions: Headache, Tension-Type

Interventions: Drug: Placebo
Drug: Paracetamol marketed formulation
Drug: ibuprofen marketed formulation
Drug: Experimental paracetamol + caffeine formulation

Registration Number: NCT01755702

Lead Sponsor: GlaxoSmithKline

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 66

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

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Placebo	Placebo
Arm 2	Paracetamol marketed formulation	paracetamol marketed forumulation
Arm 3	ibuprofen marketed formulation	ibuprofen marketed formulation
Arm 4	Experimental paracetamol + caffeine formulation	experimental paracetamol + caffeine formulation

Primary Outcome Measures

Name	Time	Method
Time to First Perceptible Headache Relief	Baseline to 6 hours	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.

Secondary Outcome Measures

Name	Time	Method
Headache Relief Scores	Baseline to 4 hours	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.
Total Pain Relief (TOTPAR)	Baseline to 4 hours	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 = Σ(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.
Sum of Pain Intensity Difference (SPID)	Baseline to 4 hours	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 = ΣPID x (time t - time t-1), where PID = PI (baseline) - PI t and PI = pain intensity.
Sum of TOTPAR and SPID (SPRID)	Baseline to 4 hours	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.
Time to Rescue Medication	Baseline to 6 hours post dose	Time to rescue medication was evaluated.
Number of Participants With Complete Headache Relief	Baseline to 2 hours	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.
Headache Severity	Baseline to 4 hours	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.
Patients Global Assessment in Response to Treatment	Baseline to 8 weeks	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.

Trial Locations

Locations (7): Biomedical Research Alliance of New York LLC
🇺🇸
Lake Success, 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
Elkind Headache Center
🇺🇸
Mount Vernon, New York, United States
MedVadis Research Corporation
🇺🇸
Wellesley Hills, Massachusetts, United States