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NCT02045901 · ClinicalTrials.gov registry record · Phase 4
A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
A Phase 4 study, sponsored by Duchesnay.
- Terminated
- Registry status
- Phase 4
- Development phase
- 131
- Enrollment target
NCT02045901: Clinical Trial Phase 4 study, sponsored by Duchesnay.
NCT02045901 is a Phase 4 study that was terminated before completion, run by Duchesnay. The registered enrollment target is 131 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02045901, a Phase 4 study, was terminated before completion, sponsored by Duchesnay.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 131 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare the efficacy of Diclegis for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo. The secondary objective of this study is to compare the safety of Diclegis in pregnant adolescents aged 12 to 17 years with placebo by assessing differences in the severity and occurrence of maternal adverse events (AEs).
Primary Outcome
The primary objective of this study is to compare the efficacy of Diclegis for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo. NVP severity will be compared using the change in PUQE and Global Assessment of Well-being scores from baseline (Day 1) to Day 15 between adolescents randomized to Diclegis and placebo for 14 days.
Interventions
- DRUG Placebo (Sugar Pill)
- DRUG Diclegis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2014-02 |
| Est. Completion | 2017-10 |
| Phase | Phase 4 |
Why NCT02045901 stopped before completion
NCT02045901 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo (Sugar Pill) is the first listed.
NCT02045901 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02045901 about?
NCT02045901 is a clinical study titled "A Multicenter Trial of the Efficacy and Safety of Diclegis® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents". The primary objective of this study is to compare the efficacy of Diclegis for the treatment of nausea and vomiting of pregnancy (NVP) in pregnant adolescents aged 12 to 17 years with placebo. The secondary objective of this study is to compare the safety of Diclegis in pregnant adolescents aged 12...
What is the current status of trial NCT02045901?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 131 participants. The study started on 2014-02. Estimated completion is 2017-10.
What interventions are being tested in trial NCT02045901?
The interventions under investigation include: Placebo (Sugar Pill) (DRUG), Diclegis (DRUG).
Who is sponsoring clinical trial NCT02045901?
This trial is sponsored by Duchesnay, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02045901's enrollment target sits among peer trials
131 619th of 2000 higher than 1,379 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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