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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Time Frame	No text entered.
Additional Description	No text entered.

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®)

Serious Adverse Events

	Diclectin®	Placebo
Total, serious adverse events
# participants affected / at risk	4/133 (3.01%)	5/128 (3.91%)
Hepatobiliary disorders
Bile duct stone ^{† 2}
# participants affected / at risk	0/133 (0.00%)	1/128 (0.78%)
# events	0	1
Pregnancy, puerperium and perinatal conditions
Intra-uterine Death ^{† 1}
# participants affected / at risk	1/133 (0.75%)	0/128 (0.00%)
# events	1	0
Abortion missed ^{† 2}
# participants affected / at risk	1/133 (0.75%)	0/128 (0.00%)
# events	1	0
Abortion spontaneous ^{† 2}
# participants affected / at risk	1/133 (0.75%)	0/128 (0.00%)
# events	1	0
Abortion spontaneous ^{† 2}
# participants affected / at risk	0/133 (0.00%)	1/128 (0.78%)
# events	0	1
Abortion spontaneous ^{† 2}
# participants affected / at risk	1/133 (0.75%)	0/128 (0.00%)
# events	1	0
Abortion missed ^{† 2}
# participants affected / at risk	0/133 (0.00%)	1/128 (0.78%)
# events	0	1
Premature rupture of membrane ^{† 2}
# participants affected / at risk	0/133 (0.00%)	1/128 (0.78%)
# events	0	1
Foetal disorder ^{† 2}
# participants affected / at risk	0/133 (0.00%)	1/128 (0.78%)
# events	0	1

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA 10.0
2	Term from vocabulary, MedDRA (10.0)

Other Adverse Events

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More Information

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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.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
N/A

Results Point of Contact:

Name/Title: Michael Gallo
Organization: Duchesnay, Inc.
phone: 450-433-7734
e-mail: mgallo@duchesnay.com

No publications provided by Duchesnay Inc.

Publications automatically indexed to this study:

Costantine MM, Matok I, Chiossi G, Clark S, Miodovnik M, Umans JG, Caritis S, Hankins GD, Koren G. Determinants of adherence to delayed-release doxylamine and pyridoxine in patients with nausea and vomiting of pregnancy. Ther Drug Monit. 2012 Oct;34(5):569-73.

Koren G, Clark S, Hankins GD, Caritis SN, Miodovnik M, Umans JG, Mattison DR. Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Am J Obstet Gynecol. 2010 Dec;203(6):571.e1-7. Epub 2010 Sep 16.

Responsible Party:	Liubov Gargaun, M.D., Duchesnay, Inc.
ClinicalTrials.gov Identifier:	NCT00614445 History of Changes
Other Study ID Numbers:	DIC-301
Study First Received:	January 29, 2008
Results First Received:	August 1, 2011
Last Updated:	August 4, 2011
Health Authority:	United States: Food and Drug Administration

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