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

NCT01842633 | Terminated Phase 3 Results

• 2 other identifiers: 202172RH01649
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 4 hours post dose

Secondary Outcomes (13)

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

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

• Number of Participants With Perceptible Pain Relief

  Baseline up to 4 hours

• Time to Perceptible Headache Relief

  Baseline up to 4 hours

• Number of Participants With Meaningful Pain Relief

  Baseline up to 4 hours

• Time to Meaningful Headache Relief

  Baseline up to 4 hours

Study Arms (3)

Paracetamol/ Caffeine Caplets

EXPERIMENTAL

Two caplets of paracetamol/caffeine combination plus 2 placebo caplets to be administered

Drug: Paracetamol and Caffeine

Ibuprofen Caplets

ACTIVE COMPARATOR

Two ibuprofen caplets plus two placebo caplets to be administered

Drug: Ibuprofen

Placebo Caplets

PLACEBO COMPARATOR

Four placebo caplets to be administered

Other: Placebo

Interventions

Paracetamol and Caffeine DRUG

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

Paracetamol/ Caffeine Caplets

Ibuprofen DRUG

Caplets containing 200 mg of ibuprofen

Ibuprofen Caplets

Placebo OTHER

Matching placebo caplets

Placebo Caplets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants in good general health, and with diagnosis of ETTH with following conditions:
• number of days with the condition is historically greater than or equal to two per month;
• severity of headaches is historically at least moderate;
• duration of headaches is historically more than or equal to 4 hours, if untreated.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

PAREXEL International, LLC

Waltham, Massachusetts, 02451, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Acetaminophen; Caffeine; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Limitations and Caveats

Enrollment into the trial was terminated after randomization of 62% of the plan resulting in a significant reduction in study power. The originally planned inferential statistics (p-values) were therefore not presented in tables summarizing results.

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2013
• First Posted: April 29, 2013
• Study Start: April 1, 2013
• Primary Completion: March 31, 2015
• Study Completion: March 31, 2015
• Last Updated: September 1, 2017
• Results First Posted: July 27, 2017

Record last verified: 2017-08

Locations

US (1)