Nausea and Vomiting of PregnancyPhase 3NCT00614445
The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
A Phase 3 study testing doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg in people with Nausea and Vomiting of Pregnancy, run by Duchesnay Inc. at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Nausea and Vomiting of Pregnancy
- What is being tested?
- doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 7 sitesUnited States
- Study dates
- Jan 2008to Dec 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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, anticholinergics, dopamine antagonists, serotonin antagonists, ginger, or anti-emetic therapy (including acupressure, acupuncture, homeopathic remedies, medical hypnosis, relief bands etc) to treat NVP in the previous 48 hours or plans to do so during the study .
- The patient is using drugs that have anticholinergic activity (e.g., tricyclic antidepressants).
- The patient is taking multivitamins containing more than 10 mg of vitamin B6, or plans to do so during the study.
Show all 11Show fewer
- The patient is taking supplementary vitamin B6 in addition to any multivitamin preparation, or plans to do so during the study.
- The patient is currently drinking any amount of alcohol.
- The patient has any condition that might interfere with the conduct of the study.
- The patient is likely to be unable to comply with study procedures because of inadequate cognitive skills.
- The patient has received an investigational drug within 30 days before enrollment in this study or is scheduled to receive an investigational drug during the course of this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
National Naval Medical Center
Bethesda, Maryland, 20889
University of Texas Medical Branch
Galveston, Texas, 77555-0587
UTMB Pasadena Clinic
Pasadena, Texas, 77502
UTMB Regional Maternal & Child Health Program--Pearland Clinic
Pearland, Texas, 77581
Magee-Womens Hospital of University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Washington Hospital Center Physicians
Washington D.C., District of Columbia, 20010
Georgetown University Hospital
Washington D.C., District of Columbia, 20057
About this study
Official title: A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
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.
Read the detailed description
Nausea and vomiting of pregnancy (NVP), also known as "morning sickness," is a common condition that affects a large percentage of pregnant women. The symptoms can range from mild nausea to severe nausea and vomiting for which a woman may need to be hospitalized. Nausea and vomiting of pregnancy can affect a woman's quality of life and ability to conduct daily activities.
Diclectin® is a combination of 10 mg doxylamine succinate (an antihistamine), and 10 mg pyridoxine hydrochloride (vitamin B6) in a delayed release tablet formulation. It has been commercially available in Canada for the management of NVP for over 25 years and has been prescribed to over 33 million pregnant women.
Presently, there is no Food Drug and Administration (FDA) approved drug on the market to treat the symptoms of NVP. This study will test the efficacy of Diclectin® (doxylamine 10 mg, pyridoxine 10 mg in a delayed-release formulation) for NVP.
Patients enrolled in the study will receive between 2 and 4 tablets of Diclectin® or placebo daily, depending on their symptoms for up to 14 days. Patients will assess their symptoms of nausea and vomiting daily using a standardized questionnaire.
- Conditions
- Nausea and Vomiting of Pregnancy
- Being tested
- doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg, Placebo
- Keywords
- Nausea, Vomiting, Pregnancy, Hyperemesis gravidarum, Pregnancy complications
- Medical subject headings
- Nausea, Vomiting, Hyperemesis Gravidarum, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mgDrug
Also called Diclectin®
up to 4 tablets daily, titrated according to the protocol
PlaceboDrug
2 to 4 tablets daily titrated according to the protocol
| Study group | Role | What they receive |
|---|---|---|
| Diclectin® | Experimental | Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet Receives: Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg |
| Placebo | Placebo comparator | Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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).
Measured: Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Nausea and Vomiting of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duchesnay Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Liubov Gargaun, M.D., Study director, Duchesnay Inc.Gideon Koren, M.D., Principal investigator, Motherisk Program, University of TorontoGary Hankins, M.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614445
- Sponsor's protocol ID
- DIC-301
- Status last verified
- Aug 2011
- First submitted
- 29 Jan 2008
- Last updated
- 23 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Persaud N, Meaney C, El-Emam K, Moineddin R, Thorpe K. Doxylamine-pyridoxine for nausea and vomiting of pregnancy randomized placebo controlled trial: Prespecified analyses and reanalysis. PLoS One. 2018 Jan 17;13(1):e0189978. doi: 10.1371/journal.pone.0189978. eCollection 2018.
PubMed 29342163Koren G, Clark S, Hankins GD, Caritis SN, Umans JG, Miodovnik M, Mattison DR, Matok I. Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. BMC Pregnancy Childbirth. 2016 Nov 24;16(1):371. doi: 10.1186/s12884-016-1172-9.
PubMed 27881103Koren G, Hankins GD, Clark S, Caritis SN, Miodovnik M, Umans JG, Mattison DR. Effectiveness of doxylamine-pyridoxine for morning sickness. Am J Obstet Gynecol. 2016 May;214(5):664-6. doi: 10.1016/j.ajog.2016.01.186. Epub 2016 Feb 1. No abstract available.
PubMed 26844757Koren G, Clark S, Hankins GD, Caritis SN, Umans JG, Miodovnik M, Mattison DR, Matok I. Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. BMC Pregnancy Childbirth. 2015 Mar 18;15:59. doi: 10.1186/s12884-015-0488-1.
PubMed 25884778Matok I, Clark S, Caritis S, Miodovnik M, Umans JG, Hankins G, Mattison DR, Koren G. Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs. J Clin Pharmacol. 2014 Dec;54(12):1429-33. doi: 10.1002/jcph.369. Epub 2014 Aug 7.
PubMed 25052410Costantine 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. doi: 10.1097/FTD.0b013e31826e7997.
PubMed 22972538Koren 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. doi: 10.1016/j.ajog.2010.07.030. Epub 2010 Sep 16.
PubMed 20843504
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
- ClinicalTrials.gov ID
- NCT00614445
- Acronym / sponsor ID
- DIC-301
- Conditions
- Nausea and Vomiting of Pregnancy
- Keywords
- Nausea, Vomiting, Pregnancy, Hyperemesis gravidarum, Pregnancy complications
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Duchesnay Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 13 Feb 2008 (estimated)
- Results
- Posted 5 Sep 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Nausea and vomiting of pregnancy (NVP), also known as "morning sickness," is a common condition that affects a large percentage of pregnant women. The symptoms can range from mild nausea to severe nausea and vomiting for which a woman may need to be hospitalized. Nausea and vomiting of pregnancy can affect a woman's quality of life and ability to conduct daily activities.
Diclectin® is a combination of 10 mg doxylamine succinate (an antihistamine), and 10 mg pyridoxine hydrochloride (vitamin B6) in a delayed release tablet formulation. It has been commercially available in Canada for the management of NVP for over 25 years and has been prescribed to over 33 million pregnant women.
Presently, there is no Food Drug and Administration (FDA) approved drug on the market to treat the symptoms of NVP. This study will test the efficacy of Diclectin® (doxylamine 10 mg, pyridoxine 10 mg in a delayed-release formulation) for NVP.
Patients enrolled in the study will receive between 2 and 4 tablets of Diclectin® or placebo daily, depending on their symptoms for up to 14 days. Patients will assess their symptoms of nausea and vomiting daily using a standardized questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclectin® | Experimental | Drug: doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mgDiclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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, anticholinergics, dopamine antagonists, serotonin antagonists, ginger, or anti-emetic therapy (including acupressure, acupuncture, homeopathic remedies, medical hypnosis, relief bands etc) to treat NVP in the previous 48 hours or plans to do so during the study .
- The patient is using drugs that have anticholinergic activity (e.g., tricyclic antidepressants).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mgAlso: Diclectin®up to 4 tablets daily, titrated according to the protocol | Drug | Diclectin® |
| Placebo2 to 4 tablets daily titrated according to the protocol | Drug | Placebo |
Primary outcome
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)
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29342163Persaud N, Meaney C, El-Emam K, Moineddin R, Thorpe K. Doxylamine-pyridoxine for nausea and vomiting of pregnancy randomized placebo controlled trial: Prespecified analyses and reanalysis. PLoS One. 2018 Jan 17;13(1):e0189978. doi: 10.1371/journal.pone.0189978. eCollection 2018.
- Derived from this study: PubMed 27881103Koren G, Clark S, Hankins GD, Caritis SN, Umans JG, Miodovnik M, Mattison DR, Matok I. Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. BMC Pregnancy Childbirth. 2016 Nov 24;16(1):371. doi: 10.1186/s12884-016-1172-9.
- Derived from this study: PubMed 26844757Koren G, Hankins GD, Clark S, Caritis SN, Miodovnik M, Umans JG, Mattison DR. Effectiveness of doxylamine-pyridoxine for morning sickness. Am J Obstet Gynecol. 2016 May;214(5):664-6. doi: 10.1016/j.ajog.2016.01.186. Epub 2016 Feb 1. No abstract available.
- Derived from this study: PubMed 25884778Koren G, Clark S, Hankins GD, Caritis SN, Umans JG, Miodovnik M, Mattison DR, Matok I. Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial. BMC Pregnancy Childbirth. 2015 Mar 18;15:59. doi: 10.1186/s12884-015-0488-1.
- Derived from this study: PubMed 25052410Matok I, Clark S, Caritis S, Miodovnik M, Umans JG, Hankins G, Mattison DR, Koren G. Studying the antiemetic effect of vitamin B6 for morning sickness: pyridoxine and pyridoxal are prodrugs. J Clin Pharmacol. 2014 Dec;54(12):1429-33. doi: 10.1002/jcph.369. Epub 2014 Aug 7.
- Derived from this study: PubMed 22972538Costantine 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. doi: 10.1097/FTD.0b013e31826e7997.
- Derived from this study: PubMed 20843504Koren 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. doi: 10.1016/j.ajog.2010.07.030. Epub 2010 Sep 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liubov Gargaun, M.D. study director
Duchesnay Inc.
Gideon Koren, M.D. principal investigator
Motherisk Program, University of Toronto
Gary Hankins, M.D. principal investigator
University of Texas
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg in people with Nausea and Vomiting of Pregnancy, run by Duchesnay Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00614445, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.