Study Evaluating A Novel Ibuprofen Formulation In Episodic Tension-Type Headache

Pain Clinical Trial

Official title:

Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Episodic Tension-Type Headache

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01077973
• Other study ID #: AH-09-11
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2010
• Last updated: July 13, 2012
• Start date: March 2010
• Est. completion date: October 2010

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Headache
• Pain
• Tension-Type Headache

Intervention

Drug:
• Novel Ibuprofen
Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
• Standard Ibuprofen
Single-dose of standard ibuprofen (400mg) plus placebo
• Placebo
Single-dose of placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-3 Hours (SPRID 0-3) for Ibuprofen Sodium Versus Placebo Tablet	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).	0 to 3 hours	No
Primary	Time to Onset of Meaningful Relief for Ibuprofen Sodium Versus Ibuprofen (Motrin IB) Tablet	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.	0 to 3 hours	No
Secondary	Time to Onset of Meaningful Relief: Remaining Comparisons	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.	0 to 3 hours	No
Secondary	Time to Confirmed First Perceptible Relief	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".	0 to 3 hours	No
Secondary	Pain Relief Rating (PRR)	PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.	1, 2, 3 hours	No
Secondary	Pain Intensity Difference (PID)	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).	1, 2, 3 hours	No
Secondary	Sum of Pain Relief Rating and Pain Intensity Difference (PRID)	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).	1, 2, 3 hours	No
Secondary	Time-weighted Sum of Pain Intensity Difference (SPID)	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).	0 to 2, 0 to 3 hours	No
Secondary	Time-weighted Sum of Pain Relief Rating (TOTPAR)	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.	0 to 2, 0 to 3 hours	No
Secondary	Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)	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).	0 to 2, 0 to 3 hours	No
Secondary	Cumulative Percentage of Participants With Meaningful Relief	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.	0.5, 1, 2, 3 hours	No
Secondary	Cumulative Percentage of Participants With Confirmed First Perceptible Relief	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".	0.5, 1, 2, 3 hours	No
Secondary	Time to Treatment Failure	Median time of dropping out of the participants from the study due to lack of efficacy or received rescue medication, whichever came first.	0 to 3 hours	No
Secondary	Cumulative Percentage of Participants With Treatment Failure	Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.	0 to 3 hours	No
Secondary	Cumulative Percentage of Participants With Complete Relief	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.	1, 2, 3 hours	No

External Links

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