Autopsy report · NCT00224419

Testing Pharmacological Therapies for Pregnant Smokers

“was terminated due to meeting a priori stopping rule set by DSMB”

The sponsor’s own words in the registry.

Life of this trial

• Registered 2 years 3 months after it had already started.
• 181 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 4

Sponsor

Duke University

Sponsor type

University, hospital or other

Conditions

Smoking; Pregnancy

Interventions

Motivational interviewing for smoking cessation; Cognitive behaviors therapy; CBT + NRT

Participants

181

Sites

2

Countries

United States

Trials that died the same way

• Soy Protein/Effexor Hormone Therapy for Prostate Cancer
  “Stopped by the DSMB for lack of effect per interim stopping rule.” (74% match in meaning)
• High Dose Chemotherapy With Amifostine and Autologous Stem Cell Transplantation for High Risk Relapsed Pediatric Solid Tumors and Brain Tumors
  “The study was terminated as recommended by the DSMB due to inability to meet enrollment goals within the time frame allotted (target of 25 patients over 5 years).” (65% match in meaning)
• Helping HIV Infected Patients in South Africa Adhere to Drug Regimens
  “DSMB stopped trial for futility” (65% match in meaning)
• Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)
  “DSMB closed due to futility.” (63% match in meaning)
• Optimizing Pediatric HIV-1 Treatment, Nairobi, Kenya
  “DSMB recommended termination because TI was safe but not durable.” (63% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.