Self-Selection and Actual Use Trial of Ibuprofen 600 mg Immediate Release/Extended Caplet

Pfizer logo

Pfizer

Status and phase

Completed
Phase 3

Conditions

Analgesia

Treatments

Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01789606
B4371008
AK-10-11 (Other Identifier)

Details and patient eligibility

About

A self-selection and actual use trial to evaluate the extent to which consumers will appropriately select and use the 600 mg immediate release/extended release caplets and comply with dosing instructions.

Enrollment

1,083 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • at least 12 years of age
  • use of at least 5 doses per month of over-the-counter pain relievers over the past 3 months
  • provide written informed consent (subjects 12-<18 years of age provide a written assent and parent/guardian will provide written informed consent)
  • capable of and willing to swallow the study medication

Exclusion criteria

  • participated in other research studies in the last 6 months
  • they or someone else in their household work for a pharmaceutical company, is a relative of study site personnel involved with the study, or an immediate family member is already enrolled in the study
  • have a history of known allergies to ibuprofen, aspirin, or other NSAIDs
  • have a history of heart surgery in the last 60 days or planned heart surgery in the next 60 days
  • female subjects are pregnant or breast feeding

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,083 participants in 1 patient group

Ibuprofen 600 mg Immediate Release/Extended Release Caplet
Experimental group
Treatment:
Drug: Ibuprofen 600 mg Immediate Release/Extended Release Caplet

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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