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NCT00614445 · ClinicalTrials.gov registry record · Phase 3
The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
A Phase 3 study, sponsored by Duchesnay.
- Completed
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
NCT00614445: Completed Phase 3 study, sponsored by Duchesnay.
NCT00614445 is a Phase 3 study that has completed, run by Duchesnay. The registered enrollment target is 280 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00614445, a Phase 3 study, has completed, sponsored by Duchesnay.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
Study Summary
The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of pregnancy than a placebo.
Primary Outcome
The objective of this double-blind, randomized, placebo-controlled study was to assess the efficacy, safety, and tolerability of oral Diclectin® in the treatment of nausea and vomiting of pregnancy (NVP) as measured by the Pregnancy Unique-Quantification of Emesis (PUQE) overall score of symptoms from baseline (Day 1) to end of study visit (Day 15). The PUQE score measured hours of nausea, number of times vomiting, and number of times retching for a TOTAL overall score of symptoms on a scale rat
Interventions
- DRUG Placebo
- DRUG doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-12 |
| Phase | Phase 3 |
What the finished NCT00614445 record still lists
NCT00614445 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (64% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00614445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00614445 about?
NCT00614445 is a clinical study titled "The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy". The purpose of this study is to determine whether Diclectin® (doxylamine succinate USP 10 mg and pyridoxine HCl 10 mg) is more effective at controlling the nausea and vomiting of pregnancy than a placebo.
What is the current status of trial NCT00614445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2008-01. Estimated completion is 2009-12.
What interventions are being tested in trial NCT00614445?
The interventions under investigation include: Placebo (DRUG), doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg (DRUG).
Who is sponsoring clinical trial NCT00614445?
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 NCT00614445's enrollment target sits among peer trials
280 1195th of 2000 higher than 802 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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