The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy (NCT00614445) | Clinical Trial Compass
CompletedPhase 3
The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
United States280 participantsStarted 2008-01
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* The patient has signed a written informed consent to participate in the study and has agreed to follow dosing instructions and complete all required study visits.
* The patient is a pregnant female age equal to or greater than 18 years old.
* The patient's entry ultrasound indicates a viable pregnancy and confirms gestational age of the fetus is 7-14 weeks at the anticipated time of the first dose of study medication or placebo. If an ultrasound was done within 4 weeks of the admission visit, and results can be obtained, an additional ultrasound is not necessary.
* The patient is suffering from NVP and has a Pregnancy Unique Quantification of Emesis (PUQE) score ≥6.
* The patient has not responded to conservative management consisting of dietary/lifestyle advice according to the 2004 ACOG Practice Bulletin.
* The patient agrees, if on a multivitamin, to continue on their current dose of multivitamin for the duration of the trial.
* The patient does not plan termination of the pregnancy.
Exclusion Criteria:
* The investigator confirms the patient's nausea and vomiting is of etiology other than Nausea and Vomiting of Pregnancy (NVP).
* The patient has gestational trophoblastic disease or multifetal gestation.
* The patient has a condition for which antihistamines, in the opinion of the investigator, are contraindicated (epilepsy, alcoholism, glaucoma, chronic lung disease, urinary retention, heart block, etc.).
* The patient has used antihistamines, ant…
What they're measuring
1
Diclectin Versus Placebo for Treatment of Nausea and Vomiting of Pregnancy (NVP) as Measured by the Change in Pregnancy Unique-Quantification of Emesis (PUQE) Overall Score of Symptoms From Baseline (Day 1) to End of Study Visit (Day 15).
Timeframe: Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)