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The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

This study has been completed.
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by:
Duchesnay Inc.
ClinicalTrials.gov Identifier:
NCT00614445
First received: January 29, 2008
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
Results First Received: August 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Nausea and Vomiting of Pregnancy
Interventions: Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This is a double-blind, randomized, multicenter, placebo-controlled study in the treatment of NVP. On Day 1, all patients will receive 2 tablets of study drug at bedtime. During Days 2-14 the patients will receive 2 tablets of study drug at bedtime plus additional study drug based upon the need for control of their nausea and vomiting.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day. After randomization, patients will return to the clinic for evaluation on Day 4 (+/-1 day) and Day 8 (+/-1 day), and will return on Day 15 (+/-1 day) for an end of study visit. The study duration is expected to be 15 days.

Reporting Groups
  Description
Diclectin® Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
Placebo Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)

Participant Flow:   Overall Study
    Diclectin®     Placebo  
STARTED     140     140  
COMPLETED     112     91  
NOT COMPLETED     28     49  



  Baseline Characteristics
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Reporting Groups
  Description
Diclectin® Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
Placebo Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
Total Total of all reporting groups

Baseline Measures
    Diclectin®     Placebo     Total  
Number of Participants  
[units: participants]
 		  140     140     280  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     140     140     280  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  25.9  ± 6.0     25.0  ± 5.6     25.5  ± 5.8  
Gender  
[units: participants]
 		     
Female     140     140     280  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
United States     140     140     280  



  Outcome Measures

1.  Primary:   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).   [ Time Frame: Baseline (Day 1) to End of Study Visit Day 15 (± 1 day) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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