Assessment of Efficacy and Safety in Relieving Opioid-induced Constipation in Patients With Cancer-related Pain

NCT01384292 on ClinicalTrials.gov Phase 3 AstraZeneca (industry) Started 2011-06-30 Terminated

Riskier than 26% of active trials

Model scores of the 29,894 trials active now.

Model score 12% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 12% of the time (422 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

Terminated on 2012-09-30, after 2011-06-30 start.

Reason given by the sponsor: “enrollment”

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 2012-09-30. 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

Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: cancerplacebobrainsclerosisbms
Phrases that lowered it: the effecteffect ofperiodpatientsand safety
Phase: 3 (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Has a data monitoring committee: not given (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 310 (raises risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports marked serious: 66.7% (lowers risk) · Drug's FDA history
Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
Sponsor's past trials: 980 (raises risk) · Sponsor's track record
Design: parallel (raises risk) · Design
Blinding: quadruple (lowers risk) · Design
Disease area, psychiatry: Yes (raises risk) · Disease area
Primary purpose: treatment (raises risk) · Design
Disease area, cancer: No (lowers risk) · Disease area
Sponsor's past termination rate: 7.8% (lowers risk) · Sponsor's track record
Minimum age: 18 (raises risk) · Who can join
Number of arms: 3 (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Collaborators: 0 (raises risk) · Design

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: 3 (typical: 2)
Allocation: randomized
Design: parallel
Primary purpose: treatment
Blinding: quadruple (typical: none)
Has a data monitoring committee: not given (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 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: 980 (typical: 32)
Sponsor's past termination rate: 7.8% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 310 (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: 3 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2 (typical: 412.5)
Drug's FAERS reports marked serious: 66.7% (typical: 85.6%)
Drug's FAERS reports with a death: 0% (typical: 15.9%)

Disease area and drugs

Disease areas: psychiatry
Drugs matched to FDA substances: naloxegol

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

Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation NCT01309841 · started 2011 · scored riskier than 35% of active trials completed
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation NCT01323790 · started 2011 · scored riskier than 39% of active trials completed
A 12-week Extension of the Phase III Study (D3820C00004) to Assess the Effect and Safety of NKTR-118 in Patients With Non-cancer-related Pain and Opioid-induced Constipation NCT01395524 · started 2011 · scored riskier than 35% of active trials completed
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation NCT01336205 · started 2011 · scored riskier than 19% of active trials completed
Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) NCT01983306 · started 2013 · scored riskier than 69% 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.