Bonjesta for Morning Sickness

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: < 18

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Duchesnay Inc.

Must not be taking: MAO inhibitors, Anticholinergics

Disqualifiers: Multifetal gestation, Epilepsy, Alcoholism, others

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing Bonjesta, a medication that helps reduce nausea and vomiting, in pregnant adolescents aged 12 to 17 years. Bonjesta combines an antihistamine and vitamin B6 to help manage these symptoms. Bonjesta combines an antihistamine and vitamin B6, which have been used separately in various studies to treat nausea and vomiting in pregnancy.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, such as antihistamines, anticholinergics, and drugs with anticholinergic activity, at least 48 hours before starting the study. You must also avoid taking any additional vitamin B6 supplements beyond your current multivitamin.

What data supports the effectiveness of the drug Bonjesta for morning sickness?

Research shows that the combination of doxylamine and pyridoxine, which is in Bonjesta, is effective for treating morning sickness. This combination is FDA-approved and has been shown to work better than a placebo in reducing nausea and vomiting during pregnancy. ^{1 2 3 4 5}

Is Bonjesta safe for treating morning sickness?

The provided research articles do not contain specific safety information about Bonjesta or its components like doxylamine/pyridoxine for morning sickness or other conditions. ^{6 7 8 9 10}

How does the drug Bonjesta differ from other treatments for morning sickness?

Bonjesta is unique because it combines doxylamine, an antihistamine, with pyridoxine (vitamin B6), which together help reduce nausea and vomiting in pregnancy. This combination is specifically formulated for morning sickness, unlike other treatments that may target different types of nausea or are not specifically designed for pregnant women. ^{6 7 11 12 13}

Research Team

Rafik Marouf, MD, PhD

Principal Investigator

Duchesnay Inc.

Eligibility Criteria

This trial is for pregnant adolescents in the US, aged 12-17 with a viable singleton pregnancy at 7-15 weeks gestation and experiencing morning sickness not improved by diet/lifestyle changes. They must be able to swallow pills whole, agree to follow study procedures, and not plan on ending their pregnancy. Those with certain health conditions or taking conflicting medications cannot participate.

Inclusion Criteria

The participant does not plan termination of the pregnancy

I tried changing my diet and lifestyle as advised but it didn't help.

I agree to keep taking my current multivitamin dose during the trial.

Exclusion Criteria

The participant has a condition for which antihistamines are contraindicated

I am taking or plan to take vitamin B6 supplements during the study.

The participant has a known hypersensitivity to specific medications

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive Bonjesta or placebo for the treatment of nausea and vomiting of pregnancy

14 days

3 visits (in-person), daily phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Bonjesta (Antiemetic)
• Placebo (Other)

Trial Overview The trial tests Bonjesta's effectiveness against placebo in treating nausea and vomiting of pregnancy (NVP) among pregnant teenagers. Participants will receive either Bonjesta or a placebo pill to compare how well each works in managing NVP symptoms.

Participant Groups

Group I: Bonjesta Active Control 1 Intervention

On Day 1, one tablet will be taken orally at bedtime. If this dose adequately controls symptoms (i.e., PUQE = 3), the participant will be directed to continue taking one tablet daily at bedtime only. However, on Day 2, if symptoms of nausea, retching and/or vomiting persist (i.e., PUQE score \>3), the participant will be directed to take her usual dose of 1 tablet at bedtime and an additional tablet the next morning on Day 3. The minimum dosage prescribed will be 1 tablet daily at bedtime, increasing, when indicated, to the maximal dosage of 2 tablets per day (one tablet in the morning and one tablet at bedtime) starting Day 3 and will continue through Day 14.

Group II: Placebo Placebo Group 1 Intervention

On Day 1, one tablet will be taken orally at bedtime. If this dose adequately controls symptoms (i.e., PUQE = 3), the participant will be directed to continue taking one tablet daily at bedtime only. However, on Day 2, if symptoms of nausea, retching and/or vomiting persist (i.e., PUQE score \>3), the participant will be directed to take her usual dose of 1 tablet at bedtime and an additional tablet the next morning on Day 3. The minimum dosage prescribed will be 1 tablet daily at bedtime, increasing, when indicated, to the maximal dosage of 2 tablets per day (one tablet in the morning and one tablet at bedtime) starting Day 3 and will continue through Day 14.

Who Is Running the Clinical Trial?

Duchesnay Inc.

Lead Sponsor

Trials

7

Recruited

2,600+

Health Decisions

Collaborator

Trials

31

Recruited

14,000+

Findings from Research

The combination of doxylamine succinate and pyridoxine hydrochloride (Diclegis®) significantly improves symptoms of nausea and vomiting in pregnancy (NVP) compared to placebo, with efficacy observed as early as Days 3, 4, and 5 of treatment.

A shorter treatment duration of just four days is sufficient to demonstrate the drug's effectiveness, which aligns with the results seen after the full 14-day treatment period, suggesting that early intervention can effectively manage NVP symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. Koren, G., Clark, S., Hankins, GD., et al.[2018]

In a randomized trial involving 256 pregnant women, Diclectin significantly improved symptoms of nausea and vomiting of pregnancy compared to placebo, with a notable difference in the pregnancy unique quantification of emesis score.

The majority of women taking Diclectin expressed a desire to continue using the medication after the trial, indicating its effectiveness and tolerability in managing their symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. Koren, G., Clark, S., Hankins, GD., et al.[2015]

Doxylamine succinate and pyridoxine hydrochloride, combined as Diclegis, is the only FDA-approved medication for treating nausea and vomiting in pregnancy (NVP), addressing a significant treatment gap since the removal of Bendectin over 30 years ago.

Diclegis has a strong safety profile, qualifying for FDA Pregnancy Category A status, making it a recommended first-tier treatment option for managing NVP due to its proven efficacy and safety in pregnant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Doxylamine succinate-pyridoxine hydrochloride (Diclegis) for the management of nausea and vomiting in pregnancy: an overview. Nuangchamnong, N., Niebyl, J.[2021]

Diclegis®, a combination of doxylamine and pyridoxine, was approved by the FDA in April 2013 as a safe treatment for morning sickness during pregnancy, classified as a pregnancy category A drug, indicating strong evidence of fetal safety.

This approval marks a significant advancement after 30 years without an FDA-approved treatment for morning sickness, providing a therapeutic option that could benefit millions of pregnant women and their healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women. Koren, G.[2020]

In a study involving 42 patients with dyspepsia, hiatus hernia, or duodenal ulcer, dicyclomine (Merbentyl) effectively controlled symptoms without the need for additional antacids or placebo treatments.

The study was conducted under double-blind conditions, showing that while patients preferred taking frequent treatments, dicyclomine alone was sufficient for symptom relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of dicyclomine with antacid and without antacid in dyspepsia. Kagan, G., Huddlestone, L., Wolstencroft, P.[2017]

In a 4-week study involving 100 patients with non-ulcer dyspepsia and erosive prepyloric changes, treatment with Al-Mg antacids and pirenzepine did not show significant superiority over placebo in improving symptoms or changing the grade of erosive prepyloric changes.

While no serious side effects were reported, xerostomia (dry mouth) was more common in patients taking pirenzepine compared to those on placebo, indicating a potential side effect of this medication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose antacids and pirenzepine in the treatment of patients with non-ulcer dyspepsia and erosive prepyloric changes. A randomized, double-blind, placebo-controlled trial. Weberg, R., Berstad, A.[2019]

In a case of severe diphenhydramine-induced antimuscarinic delirium, the combination of physostigmine and transdermal rivastigmine was effective in resolving symptoms without any observed adverse effects, suggesting rivastigmine as a potential alternative during physostigmine shortages.

The patient experienced persistent antimuscarinic symptoms like dry mouth and difficulty urinating after rivastigmine was discontinued, but did not develop muscarinic toxicity, indicating that rivastigmine can be safely used in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diphenhydramine-Induced Antimuscarinic Delirium Treated with Physostigmine and Transdermal Rivastigmine. Whitledge, JD., Watson, CJ., Simpson, M., et al.[2023]

Pralidoxime was successfully used to treat a pediatric patient who ingested rivastigmine, showing clinical improvement in symptoms of cholinergic syndrome after administration.

This case suggests that pralidoxime can be an effective treatment for acetylcholinesterase inhibitor poisoning, as indicated by the patient's increased plasma cholinesterase levels following treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The First Use of Pralidoxime in a Child With Rivastigmine Poisoning. Saz, EU., Yurtseven, A., Kilinç, MA., et al.[2018]

The herbal medicinal product STW 5 has been shown to be an effective alternative to metoclopramide and cisapride for treating functional gastrointestinal disorders, supported by randomized controlled trials.

STW 5 has a favorable safety profile, allowing for long-term use in patients without the restrictions that apply to other prokinetic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of gastrointestinal motility beyond metoclopramide and domperidone : Pharmacological and clinical evidence for phytotherapy in functional gastrointestinal disorders. Madisch, A., Vinson, BR., Abdel-Aziz, H., et al.[2018]

A new chewable tablet formulation combining meclizine and pyridoxine has been developed to provide rapid absorption and improve patient acceptance, especially for those experiencing nausea and vomiting.

The formulation demonstrated excellent dissolution profiles and was well-received in taste tests, indicating its potential as an effective and palatable treatment option for motion sickness across all age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Formulation of New Chewable Oral Dosage Forms of Meclizine and Pyridoxine Hydrochloride. Al-Madhagi, WM., Alshargabi, A., Alzomor, AKY., et al.[2023]

In a study involving 20 participants with motion sickness, the transdermal system Scopoderm TTS (scopolamine) was found to be as effective as the oral antiemetic dimenhydrinate during a 1-hour test flight.

Scopoderm TTS offers a significant advantage for long-distance travel, providing effective motion sickness prevention for up to 72 hours, compared to the shorter duration of dimenhydrinate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative in-flight study of a scopolamine-containing membrane plaster versus dimenhydrinate under defined acceleration conditions]. Offenloch, K., Zahner, G., Dietlein, G., et al.[2018]

In a study of 28 patients with suspected gastrointestinal motility disorders, neostigmine significantly increased motor activity in the stomach and small intestine, indicating its potential efficacy in treating conditions like gastroparesis and intestinal dysmotility.

The increase in motor activity was observed in a majority of patients with reduced contractile responses after meals, but interestingly, the effects were not more pronounced in patients with cardiovagal dysfunction, suggesting that the mechanism of action may not be influenced by this specific type of nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of neostigmine on gastroduodenal motility in patients with suspected gastrointestinal motility disorders. Parthasarathy, G., Ravi, K., Camilleri, M., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of delayed-release doxylamine and pyridoxine for nausea and vomiting of pregnancy: a randomized placebo controlled trial. [2015]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Doxylamine succinate-pyridoxine hydrochloride (Diclegis) for the management of nausea and vomiting in pregnancy: an overview. [2021]

4. Australia pubmed.ncbi.nlm.nih.gov

The return to the USA of doxylamine-pyridoxine delayed release combination (Diclegis®) for morning sickness--a new morning for American women. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

Nausea and vomiting of pregnancy. Evidence-based treatment algorithm. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Comparison of dicyclomine with antacid and without antacid in dyspepsia. [2017]

7. England pubmed.ncbi.nlm.nih.gov

Low-dose antacids and pirenzepine in the treatment of patients with non-ulcer dyspepsia and erosive prepyloric changes. A randomized, double-blind, placebo-controlled trial. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Diphenhydramine-Induced Antimuscarinic Delirium Treated with Physostigmine and Transdermal Rivastigmine. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

The First Use of Pralidoxime in a Child With Rivastigmine Poisoning. [2018]

10. Austria pubmed.ncbi.nlm.nih.gov

Modulation of gastrointestinal motility beyond metoclopramide and domperidone : Pharmacological and clinical evidence for phytotherapy in functional gastrointestinal disorders. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Formulation of New Chewable Oral Dosage Forms of Meclizine and Pyridoxine Hydrochloride. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

[Comparative in-flight study of a scopolamine-containing membrane plaster versus dimenhydrinate under defined acceleration conditions]. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Effect of neostigmine on gastroduodenal motility in patients with suspected gastrointestinal motility disorders. [2018]