MARC details
| 000 -LEADER |
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| fixed length control field |
03687nam a22005177a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
170411s20162016 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1471-2393 |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
27881103 |
| 245 ## - TITLE STATEMENT |
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| Title |
Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. |
| 251 ## - Source |
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| Source |
BMC Pregnancy & Childbirth. 16(1):371, 2016 Nov 24 |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
BMC Pregnancy Childbirth. 16(1):371, 2016 Nov 24 |
| 253 ## - Journal Name |
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| Journal name |
BMC pregnancy and childbirth |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2016 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2017 |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2017-05-24 |
| 501 ## - WITH NOTE |
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| Local holdings |
Available online from MWHC library: 2001 - present |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
BACKGROUND: Nausea and vomiting of pregnancy (NVP) affects up to 80% of expecting mothers. In April 2013 the FDA approved the delayed-release combination of doxylamine succinate and pyridoxine hydrochloride (Diclegis) for NVP, based in part, on the results of a phase III randomized trial demonstrating the efficacy of this drug combination [study drug marketed under the trade name Diclectin in Canada and Diclegis in the United States] compared to placebo in pregnant women. Study drug dosing occurred for 14 days, which is substantially longer than what has been performed in similar studies. The objective of this study was to evaluate, through secondary analysis, whether the primary measure of efficacy can be demonstrated after five days of treatment. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
CONCLUSION: A four day study drug dosing trial with Diclegis is sufficient to document efficacy, as the results are similar to those achieved after 14 study drug dosing days. The benefit seen at the earlier time validates drug efficacy and minimizes the natural course of improvement. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
METHODS: Women suffering from NVP were randomized to receive Diclegis (n=131) or placebo (n=125) for 14 days at doses ranging from two to four tablets a day, based on a pre-specified titration protocol. The primary efficacy endpoint was the change in the validated Pregnancy-Unique Quantification of Emesis (PUQE) score at baseline versus Day 15 between Diclegis-treated and placebo-treated women. For the present study, the change in PUQE score between baseline and Day 15 (end of the study) was compared to the changes observed for Days 3, 4, and 5. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
RESULTS: The use of delayed-release doxylamine succinate and pyridoxine hydrochloride tablets show improved NVP symptom control as compared to placebo on Days 3,4 and 5, with sustained efficacy until the end of the trial. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
TRIAL REGISTRATION: CTR No. NCT006 14445 2007. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Antiemetics/tu [Therapeutic Use] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Dicyclomine/tu [Therapeutic Use] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Doxylamine/tu [Therapeutic Use] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Morning Sickness/dt [Drug Therapy] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Pyridoxine/tu [Therapeutic Use] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Antiemetics/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Delayed-Action Preparations |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Dicyclomine/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Doxylamine/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Drug Combinations |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Female |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Pregnancy |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Pyridoxine/ad [Administration & Dosage] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Time Factors |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Health Research Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Miodovnik, Menachem |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Umans, Jason G |
| 790 ## - Authors |
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| All authors |
Caritis SN, Clark S, Hankins GD, Koren G, Matok I, Mattison DR, Miodovnik M, Umans JG |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1186/s12884-016-1172-9">https://dx.doi.org/10.1186/s12884-016-1172-9</a> |
| Public note |
https://dx.doi.org/10.1186/s12884-016-1172-9 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
