Paracetamol With Caffeine to Treat Episodic Tension Type Headache

NCT01755702 | Terminated Phase 2 Results

• 1 other identifier: A2260597
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 7

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.

Conditions

Headache, Tension-Type

Keywords

caffeine; paracetamol; tension headache

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Headache Relief Scores

  Baseline to 4 hours

• Total Pain Relief (TOTPAR)

  Baseline to 4 hours

• Sum of Pain Intensity Difference (SPID)

  Baseline to 4 hours

• Sum of TOTPAR and SPID (SPRID)

  Baseline to 4 hours

• Time to Rescue Medication

  Baseline to 6 hours post dose

Study Arms (4)

Arm 1

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Arm 2

ACTIVE COMPARATOR

paracetamol marketed forumulation

Drug: Paracetamol marketed formulation

Arm 3

ACTIVE COMPARATOR

ibuprofen marketed formulation

Drug: ibuprofen marketed formulation

Arm 4

EXPERIMENTAL

experimental paracetamol + caffeine formulation

Drug: Experimental paracetamol + caffeine formulation

Interventions

Placebo DRUG

Placebo

Arm 1

Experimental paracetamol + caffeine formulation DRUG

experimental paracetamol + caffeine formulation

Arm 4

ibuprofen marketed formulation DRUG

ibuprofen marketed formulation

Arm 3

Paracetamol marketed formulation DRUG

Paracetamol marketed formulation

Arm 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of episodic tension-type headache consistent with all of the following:
• number of days with the condition is historically greater than or equal to two per month
• onset of condition was greater than or equal to 12 months from Visit 1
• age of onset was \< 50 years
• severity of headaches is historically at least moderate
• duration of headaches is historically greater than or equal to four hours, if untreated
• 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
• treatment of headache episodes with OTC analgesics has historically provided pain relief in less than or equal to 2 hours

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

University Clinical Research, Inc.

Pembroke Pines, Florida, 33024, United States

Location

Springfield Neurology Associates

Springfield, Massachusetts, 01104, United States

Location

MedVadis Research Corporation

Wellesley Hills, Massachusetts, 02481, United States

Location

Biomedical Research Alliance of New York LLC

Lake Success, New York, 11042, United States

Location

Elkind Headache Center

Mount Vernon, New York, 10550, United States

Location

International Research Service, Inc.

Port Chester, New York, 10573, United States

Location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2011
• First Posted: December 24, 2012
• Study Start: July 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 27, 2015
• Results First Posted: March 27, 2015

Record last verified: 2014-11

Locations

US (7)