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Trial record 1 of 1 for:    NCT01077973
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Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

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ClinicalTrials.gov Identifier: NCT01077973
Recruitment Status : Completed
First Posted : March 1, 2010
Results First Posted : August 20, 2012
Last Update Posted : August 20, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 26, 2010
First Posted Date  ICMJE March 1, 2010
Results First Submitted Date  ICMJE July 12, 2012
Results First Posted Date  ICMJE August 20, 2012
Last Update Posted Date August 20, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
  • 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 to 3 hours ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
Time-weighted sum of pain relief & pain intensity difference scores over 3 hours & Time to onset of meaningful relief [ Time Frame: 0-3 hours ]
Change History Complete list of historical versions of study NCT01077973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2012)
  • Time to Onset of Meaningful Relief: Remaining Comparisons [ Time Frame: 0 to 3 hours ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 Confirmed First Perceptible Relief [ Time Frame: 0.5, 1, 2, 3 hours ]
    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".
  • Time to Treatment Failure [ Time Frame: 0 to 3 hours ]
    Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first.
  • Cumulative Percentage of Participants With Treatment Failure [ Time Frame: 0 to 3 hours ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2010)
Time to 1st perceptible relief(FPR); pain relief(PR), pain intensity difference(PID), sum of PR&PID; Sum of PID; Time-weighted sum of PR; Time-weighted sum of PR&PID; cumulative proportion treatment failures, meaningful & FPR; Duration & complete relief [ Time Frame: 0-3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache
Official Title  ICMJE Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache
Brief Summary 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 episodic tension-type headache.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pain
Intervention  ICMJE
  • Drug: Novel Ibuprofen
    Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
  • Drug: Standard Ibuprofen
    Single-dose of standard ibuprofen (400mg) plus placebo
  • Drug: Placebo
    Single-dose of placebo
Study Arms  ICMJE
  • Experimental: Treatment A
    Intervention: Drug: Novel Ibuprofen
  • Active Comparator: Treatment B
    Intervention: Drug: Standard Ibuprofen
  • Placebo Comparator: Treatment C
    Intervention: Drug: Placebo
Publications * Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. Epub 2014 Dec 15.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2010)
200
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2010)
80
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
  • A history of episodic tension-type headache with the following characteristics: 4 headache episodes per month for the last 6 months of moderately severe intensity; headache generally lasts more than 3 hours if left untreated; adequate headache relief is generally obtained with over-the-counter (OTC) doses of OTC analgesics

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Alcohol or substance abuse
  • Any serious medical or psychiatric disorder
  • History of stomach ulcers, stomach bleed, or other bleeding disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01077973
Other Study ID Numbers  ICMJE AH-09-11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP