Bioequivalence of a Fixed Dose Combination Tablet Containing 200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl Compared to RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) as a Fixed Dose Combination Tablet Administered in Healthy Volunteers.

NCT01170637 on ClinicalTrials.gov Phase 1 Boehringer Ingelheim (industry) Started 2010-07-31 Completed

Riskier than 4% of active trials

Model scores of the 29,894 trials active now.

Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).

Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

How it ended

Completed.

The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.

Termination over time, as the model saw it at the start

Cumulative chance of ending terminated (red) or completed (green) by each year from its start. The rest of the way to 100% is still running.

From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.

What moved the score

Accepts healthy volunteers: Yes (lowers risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: intervalheartpriorqtms
Phrases that lowered it: healthytabletadministrationexaminationkg
Phase: 1 (lowers risk) · Design
Minimum age: 21 (lowers risk) · Who can join
Design: single group (raises risk) · Design
Has a data monitoring committee: not given (lowers risk) · Design
Sponsor's past termination rate: 4.4% (lowers risk) · Sponsor's track record
Trials the sponsor started in the prior 2 years: 180 (lowers risk) · Sponsor's track record
Responsible party: not given (raises risk) · Design
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: none (lowers risk) · Design
Drug's FAERS reports with a death: 17.7% (lowers risk) · Drug's FDA history
Sponsor's past trials: 90 (lowers risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Number of arms: 4 (lowers risk) · Design
Drug's FAERS reports in the prior 12 months: 16134 (lowers risk) · Drug's FDA history

Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: 4 (typical: 2)
Allocation: randomized
Design: single group (typical: parallel)
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: not given (typical: sponsor)
Collaborators: 0
Keywords listed: 0 (typical: 1)

Who can join

Minimum age: 21 (typical: 18)
Maximum age: 50 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 90 (typical: 32)
Sponsor's past termination rate: 4.4% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 180 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 3 (typical: 1)
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 88449 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 16134 (typical: 412.5)
Drug's FAERS reports marked serious: 83.3% (typical: 85.6%)
Drug's FAERS reports with a death: 17.7% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: acetaminophen, ibuprofen, pseudoephedrine

Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.

Similar finished trials

Bioequivalence of a Fixed Dose Combination Tablet Containing 400 mg Ibuprofen and 60 mg Pseudoephedrine-HCl Compared to Two Film Coated Fixed Dose Combination Tablets RhinAdvil(R)(200 mg Ibuprofen and 30 mg Pseudoephedrine-HCl) Administered in Healthy Subjects NCT02963701 · started 2016 · scored riskier than 3% of active trials completed
Ibuprofen and Pseudoephedrine Comparative Pharmacokinetic Study NCT03184766 · started 2016 · scored riskier than 0% of active trials completed
A Multiple-Dose PK Study to Evaluate the Comparative Bioavailability of PrimeC Tablets to Ciprofloxacin Tablets Co-administered With Celecoxib Capsules, in Healthy Adult Subject NCT05436678 · started 2022 · scored riskier than 0% of active trials completed
A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects NCT05232461 · started 2022 · scored riskier than 0% of active trials completed
Ibuprofen Bioavailability Trial With Oral Single Dose Administration. NCT03018015 · started 2016 · scored riskier than 0% of active trials completed

Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.