Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis.

NCT01641393 on ClinicalTrials.gov Phase 3 Forest Laboratories (industry) Started 2012-06-30 Completed

Riskier than 8% of active trials

Model scores of the 29,894 trials active now.

Model score 7% for any early termination, 3% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 6% of the time (528 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 on 2014-02-28, after 2012-06-30 start.

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; it actually ended on 2014-02-28. 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

Design: crossover (lowers risk) · Design
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: pancreatictransplantationin subjectsevidence ofuncontrolled
Phrases that lowered it: bmikgscreeningmass indexbody mass
Accepts healthy volunteers: No (raises risk) · Who can join
Sponsor's past termination rate: 9.8% (raises risk) · Sponsor's track record
Has a data monitoring committee: Yes (raises risk) · Design
Phase: 3 (lowers risk) · Design
Drug's FAERS reports with a death: 8.3% (lowers risk) · Drug's FDA history
Blinding: quadruple (lowers risk) · Design
Drug's FAERS reports marked serious: 64.2% (lowers risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Trials the sponsor started in the prior 2 years: 30 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Disease area, digestive: Yes (raises risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Sponsor's past trials: 82 (lowers risk) · Sponsor's track record

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: 3 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 12 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 82 (typical: 32)
Sponsor's past termination rate: 9.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 30 (typical: 19)

Drug's FDA history

Drugs with FDA adverse-event history: 1
Drug has FAERS history: Yes (typical: 64% yes)
Drug's FAERS reports before start: 422 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 104 (typical: 412.5)
Drug's FAERS reports marked serious: 64.2% (typical: 85.6%)
Drug's FAERS reports with a death: 8.3% (typical: 15.9%)

Disease area and drugs

Disease areas: respiratory, digestive
Drugs matched to FDA substances: pancrelipase

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

OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis NCT03746483 · started 2019 · scored riskier than 25% of active trials completed
OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis NCT04375878 · started 2020 · scored riskier than 18% of active trials completed
Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF) NCT00690820 · started 2008 · scored riskier than 23% of active trials completed
Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis NCT01710644 · started 2013 · scored riskier than 9% of active trials completed
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis NCT02279498 · started 2015 · scored riskier than 24% 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.