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Trial record 4 of 8 for:    UNISOM OR Unisom OR DOXYLAMINE OR Doxy-Sleep-Aid OR DOXYLAMINE SUCCINATE OR DECAPRYN OR Decapryn OR DOXY-SLEEP-AID

The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy

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ClinicalTrials.gov Identifier: NCT00614445
Recruitment Status : Completed
First Posted : February 13, 2008
Results First Posted : September 5, 2011
Last Update Posted : September 5, 2011
Sponsor:
Collaborator:
Premier Research Group plc
Information provided by:
Duchesnay Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Nausea and Vomiting of Pregnancy
Interventions Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
Drug: Placebo
Enrollment 280
Recruitment Details 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 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.
Arm/Group Title Diclectin® Placebo
Hide Arm/Group Description Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
Period Title: Overall Study
Started 140 140
Completed 112 91
Not Completed 28 49
Arm/Group Title Diclectin® Placebo Total
Hide Arm/Group Description Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®) Total of all reporting groups
Overall Number of Baseline Participants 140 140 280
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 280 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
140
 100.0%
140
 100.0%
280
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 140 participants 280 participants
25.9  (6.0) 25.0  (5.6) 25.5  (5.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 140 participants 280 participants
Female
140
 100.0%
140
 100.0%
280
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 140 participants 140 participants 280 participants
140 140 280
1.Primary Outcome
Title 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).
Hide Description 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 rated from 3 (no symptoms) to 15 (most severe).
Time Frame Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
Planned: Approximately 280 subjects (140 subjects per treatment group) were to be enrolled to achieve 200 evaluable subjects. Analyzed: 280 enrolled subjects [261 subjects in the intent-to-treat safety (ITT-S) population; 256 subjects in the intent-to-treat efficacy (ITT-E) population].
Arm/Group Title Diclectin® Placebo
Hide Arm/Group Description:
Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
Overall Number of Participants Analyzed 140 140
Mean (95% Confidence Interval)
Unit of Measure: PUQE Score
-4.8
(-5.26 to -4.34)
-3.9
(-4.36 to -3.44)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Diclectin® Placebo
Hide Arm/Group Description Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
All-Cause Mortality
Diclectin® Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Diclectin® Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/133 (3.01%)      5/128 (3.91%)    
Hepatobiliary disorders     
Bile duct stone  2  0/133 (0.00%)  0 1/128 (0.78%)  1
Pregnancy, puerperium and perinatal conditions     
Intra-uterine Death  1  1/133 (0.75%)  1 0/128 (0.00%)  0
Abortion missed  2  1/133 (0.75%)  1 0/128 (0.00%)  0
Abortion spontaneous  2  1/133 (0.75%)  1 0/128 (0.00%)  0
Abortion spontaneous  2  0/133 (0.00%)  0 1/128 (0.78%)  1
Abortion missed  2  0/133 (0.00%)  0 1/128 (0.78%)  1
Premature rupture of membrane  2  0/133 (0.00%)  0 1/128 (0.78%)  1
Foetal disorder  2  0/133 (0.00%)  0 1/128 (0.78%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
2
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Diclectin® Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/133 (48.87%)      63/128 (49.22%)    
Gastrointestinal disorders     
Adominal Pain  1  5/133 (3.76%)  5 8/128 (6.25%)  8
General disorders     
Fatigue  1  9/133 (6.77%)  9 8/128 (6.25%)  8
Musculoskeletal and connective tissue disorders     
Back pain  1  7/133 (5.26%)  7 4/128 (3.13%)  4
Nervous system disorders     
Dizziness  1  8/133 (6.02%)  8 8/128 (6.25%)  8
Headache  1  17/133 (12.78%)  17 20/128 (15.63%)  20
Somnolence  1  19/133 (14.29%)  19 15/128 (11.72%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
No unpublished data given to the investigator may be transmitted to a third party without prior approval of the sponsor in writing. No publications or communications involving the results of the trial are authorized without prior review and written consent from the sponsor. The investigator must agree to send the sponsor for review prior to their submission. The sponsor reserves the right to delete from such materials any part or parts deemed to be confidential or proprietary.
Results Point of Contact
Name/Title: Michael Gallo
Organization: Duchesnay, Inc.
Phone: 450-433-7734
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Liubov Gargaun, M.D., Duchesnay, Inc.
ClinicalTrials.gov Identifier: NCT00614445     History of Changes
Other Study ID Numbers: DIC-301
First Submitted: January 29, 2008
First Posted: February 13, 2008
Results First Submitted: August 1, 2011
Results First Posted: September 5, 2011
Last Update Posted: September 5, 2011