NCT03722238

Actual Use and Compliance Study Of Ibuprofen 600 Mg Immediate Release/Extended Release Tablets In At-Risk OTC Consumers

Terminated Phase 3 Results posted Last updated 24 September 2021

What this trial tests

Phase 3 trial testing Ibuprofen 600 mg Immediate Release/Extended Release Caplet in Pain in 613 participants. Terminated before completion.

Timeline

27 December 2018

Primary endpoint
28 October 2019

28 October 2019

Quick facts

Lead sponsor	Pfizer
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	parallel
Masking	none
Primary purpose	other
Enrollment	613
Start date	27 December 2018
Primary completion	28 October 2019
Estimated completion	28 October 2019
Sites	27 locations across United States

Drugs / interventions tested

• Ibuprofen 600 mg Immediate Release/Extended Release Caplet — full drug profile →

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Pfizer — full company profile →

Who can join

12 and older, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period Primary · From first purchase of study drug (Day 1) to Day 30

Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	10.6	6.1 – 15.1
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period Primary · From first purchase of study drug (Day 1) to Day 30

Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	7.8	3.9 – 11.8
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period Primary · From first purchase of study drug (Day 1) to Day 30

Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	7.3	3.5 – 11.1
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 2 or More Calendar Days During the Use Period Primary · From first purchase of study drug (Day 1) to Day 30

Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	2.8	0.4 – 5.2
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period Secondary · From first purchase of study drug (Day 1) to Day 30

Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	22.9	16.7 – 29.1
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period Secondary · From first purchase of study drug (Day 1) to Day 30

Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	16.2	10.8 – 21.6
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period Secondary · From first purchase of study drug (Day 1) to Day 30

Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	14.0	8.9 – 19.0
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During the Use Period Secondary · From first purchase of study drug (Day 1) to Day 30

Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	6.1	2.6 – 9.7
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 1 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse Secondary · From first purchase of study drug (Day 1) to Day 30

Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	3.4	0.7 – 6.0
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 2 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse Secondary · From first purchase of study drug (Day 1) to Day 30

Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	2.2	0.1 – 4.4
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 3 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse Secondary · From first purchase of study drug (Day 1) to Day 30

Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	2.2	0.1 – 4.4
Adolescent Users	0.0	0.0 – 0.0

Percentage of Participants in Data Analysis Set 4 Exceeding the Maximum Daily Dose of 1200 mg on 1 or More Calendar Days During Use Period Due to Unintentional Misuse Secondary · From first purchase of study drug (Day 1) to Day 30

Unintentional misuse: Participants who did not understand the dosing instructions on the package. Use period was defined as 30 days from purchase.

Group	Value	95% CI
Adult Compliance-Evaluable Population	2.2	0.1 – 4.4
Adolescent Users	0.0	0.0 – 0.0

Adverse events — posted to ClinicalTrials.gov

Time frame: First purchase of study drug up to maximum of 45 days after last dose of study drug (for up to 75 days). Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Adult Compliance-Evaluable Population

Serious: 4/198 (2%)

Deaths: 1/198

Adolescent Users

Serious: 0/5 (0%)

Deaths: 0/5

Serious adverse events (5 terms)

Reaction	System	Adult Compliance-Evaluable…	Adolescent Users
Victim of crime	Social circumstances	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—
Depression	Psychiatric disorders	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Death	General disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Adult Compliance-Evaluable…	Adolescent Users
Nasopharyngitis	Infections and infestations	—	—
Nausea	Gastrointestinal disorders	—	—

Most-reported serious reactions: Victim of crime, Pancreatitis acute, Depression, Hypoglycaemia, Death.

Data from ClinicalTrials.gov NCT03722238 adverse events section.

Sponsor's own description

This will be an open-label, multicenter, 30-day, unsupervised AUS among targeted (at-risk) adult and adolescent consumers designed to mimic an OTC-like environment. More specifically, "at-risk" consumers, as discussed with the FDA, will comprise elderly consumers (\>65 years of age), consumers with an increased risk of gastrointestinal (GI) bleeding or cardiovascular (CV) adverse events, consumers who experience severe pain, low literacy subjects, and adolescents (12-17 years of age). The total number of subjects expected to enroll into the study is approximately 820. Sites will be pharmacies in diverse geographic locations around the US. Prospective adult subjects will be recruited via general population and targeted risk condition advertising (although participants will not be informed as to specific health conditions for which they are being recruited), while adolescents will be recruited using targeted, outbound pre-recruiting telephone calls. Subjects (or the parents/guardians of prospective adolescent subjects) responding to the advertisements or recruitment calls will be initially screened by telephone, and eligibility will subsequently be verified in-person at the pharmacy site.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.