Ibuprofen Sodium Tension Headache Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01362491
First received: May 19, 2011
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache


Condition Intervention Phase
Pain
Drug: Ibuprofen Sodium
Drug: Standard Ibuprofen
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ibuprofen Sodium Tension Headache Study

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet [ Time Frame: 0-3 Hours ] [ Designated as safety issue: No ]
    SPRID:time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 3 hours. SPRID score range:-3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of pain intensity differences (PID) and pain relief rating(PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best). PRR:assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).

  • Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet [ Time Frame: 0 to 3 hours ] [ Designated as safety issue: No ]
    Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.


Secondary Outcome Measures:
  • Time to Onset of Meaningful Relief: Remaining Comparisons [ Time Frame: 0 to 3 hours ] [ Designated as safety issue: No ]
    Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.

  • Time to Confirmed First Perceptible Relief [ Time Frame: 0 to 3 hours ] [ Designated as safety issue: No ]
    Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful".

  • Pain Relief Rating (PRR) [ Time Frame: 1, 2 & 3 hours post-dose ] [ Designated as safety issue: No ]
    PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.

  • Pain Intensity Difference (PID) [ Time Frame: 1, 2 & 3 hours post-dose ] [ Designated as safety issue: No ]
    PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best).

  • Sum of Pain Relief Rating and Pain Intensity Difference (PRID) [ Time Frame: 1, 2 & 3 hours post-dose ] [ Designated as safety issue: No ]
    PRID was sum of PID and PRR at each post-dosing time point. The overall possible score range, for PRID was -1 (worst) to 7 (best). PID was derived by subtracting the pain severity score at a given post-dosing time point [pain severity score range 0 (none) to 3 (severe)] from the baseline score [Baseline pain severity score range 2 (moderately severe) to 3 (severe)]. Total possible score range for PID: -1 (worst) to 3 (best). PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).

  • Time-weighted Sum of Pain Intensity Difference (SPID) [ Time Frame: 0 to 2, 0 to 3 hours ] [ Designated as safety issue: No ]
    SPID: time-weighted sum of PID over 2 and 3 hours. SPID score range was -2(worst) to 6 (best) for SPID 0-2 and -3 (worst) to 9 (best) for SPID 0-3. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3 (best).

  • Time-weighted Sum of Pain Relief Rating (TOTPAR) [ Time Frame: 0 to 2, 0 to 3 hours ] [ Designated as safety issue: No ]
    TOTPAR: time-weighted sum of PRR over 2 and 3 hours. TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2 and 0 (worst) to 12 (best) for TOTPAR 0-3. PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.

  • Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID) [ Time Frame: 0 to 2, 0 to 3 hours ] [ Designated as safety issue: No ]
    SPRID: time-weighted sum of PRID over 2 and 3 hours. SPRID score range was -2(worst) to 14(best) for SPRID 0-2 and -3 (worst) to 21 (best) for SPRID 0-3. PRID: sum of PID and PRR at each time point. Total score range for PRID: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (score range 0=none to 3=severe; baseline score range 2=moderately severe to 3=severe). Total score range for PID: -1(worst) to 3(best), PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).

  • Cumulative Percentage of Participants With Meaningful Relief [ Time Frame: 0.5, 1, 2, 3 hours ] [ Designated as safety issue: No ]
    Percentage of participants with meaningful relief evaluated by stopping a second stopwatch labeled 'meaningful relief' at the moment the participant first began to experience meaningful relief. It was also considered achieved if the participant stated "meaningful relief" at the time the first stopwatch was depressed. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered.

  • Cumulative Percentage of Participants With First Perceptible Relief [ Time Frame: 0.5, 1, 2, 3 hours ] [ Designated as safety issue: No ]
    Percentage of participants with first perceptible relief evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief. Stopwatch was active up to 3 hours after dosing or until stopped by the participant, or rescue medication was administered. First perceptible relief was considered confirmed by meaningful relief if the participant achieved both "first perceptible" and "meaningful" relief by either depressing the second stopwatch or by indicating that his/her "first perceptible" relief was also "meaningful".

  • Duration of Relief [ Time Frame: 0 to 3 hours ] [ Designated as safety issue: No ]
    Median participant time for dropping out of the study due to lack of efficacy or receipt of rescue medication, whichever came first.

  • Cumulative Percentage of Participants With Treatment Failure [ Time Frame: 1, 2, 3 hours post-dose ] [ Designated as safety issue: No ]
    Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.

  • Cumulative Percentage of Participants With Complete Relief [ Time Frame: 1, 2, & 3 hours post-dose ] [ Designated as safety issue: No ]
    Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief


Enrollment: 226
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A Drug: Ibuprofen Sodium
Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen)
Active Comparator: Treatment B Drug: Standard Ibuprofen
Single-dose of standard ibuprofen tablets (400mg)
Placebo Comparator: Treatment C Drug: Placebo
Single-dose of placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females at least 18 years to 65 years of age
  • A diagnosis of an episodic tension-type headache, as defined by the International Headache Society

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Alcohol or substance abuse
  • Any serious medical or psychiatric disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362491

Locations
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19145
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01362491     History of Changes
Other Study ID Numbers: AH-11-16, B3411007
Study First Received: May 19, 2011
Results First Received: March 7, 2013
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Headache

Additional relevant MeSH terms:
Headache
Tension-Type Headache
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Ibuprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014