Trial · NCT00614445
The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
NCT00614445, Phase 3, Completed, Duchesnay Inc.; results first posted 2011-09-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy. Trials, record NCT00614445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00614445
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
- NCT number
- NCT00614445
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 280 participants, actual
- Lead sponsor
- Duchesnay Inc.
- Conditions
- Nausea and Vomiting of Pregnancy
- Interventions
- doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg, Placebo
- First posted
- 2008-02-13
- Last updated
- 2021-11-23
- Results first posted
- 2011-09-05
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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). | 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). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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). | Baseline (Day 1) to End of Study Visit Day 15 (± 1 day) | Planned: Approximately 280 subjects (140 subjects per treatment group) were to be enrolled to achieve 200 evaluable subjects. Analyzed: 280 enrolled subjects \[261 subjects in the intent-to-treat safety (ITT-S) population; 256 subjects in the intent-to-treat efficacy (ITT-E) population\]. | PUQE Score | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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). | Diclectin® | -4.8 | 95% Confidence Interval -5.26 to -4.34 | PUQE Score | |
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). | Placebo | -3.9 | 95% Confidence Interval -4.36 to -3.44 | PUQE Score |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Diclectin® | 140 | |
| Overall Study | STARTED | Placebo | 140 | |
| Overall Study | COMPLETED | Diclectin® | 112 | |
| Overall Study | COMPLETED | Placebo | 91 | |
| Overall Study | NOT COMPLETED | Diclectin® | 28 | |
| Overall Study | NOT COMPLETED | Placebo | 49 |
Source ClinicalTrials.gov
Adverse events28
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Adominal Pain | Gastrointestinal disorders | Diclectin® | 5 | 133 | 5 |
| other | Adominal Pain | Gastrointestinal disorders | Placebo | 8 | 128 | 8 |
| other | Fatigue | General disorders | Diclectin® | 9 | 133 | 9 |
| other | Fatigue | General disorders | Placebo | 8 | 128 | 8 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Diclectin® | 7 | 133 | 7 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Placebo | 4 | 128 | 4 |
| other | Dizziness | Nervous system disorders | Diclectin® | 8 | 133 | 8 |
| other | Dizziness | Nervous system disorders | Placebo | 8 | 128 | 8 |
| other | Headache | Nervous system disorders | Diclectin® | 17 | 133 | 17 |
| other | Headache | Nervous system disorders | Placebo | 20 | 128 | 20 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Diclectin® | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Diclectin® | 65 | 133 |
| Total, other adverse events | Placebo | 63 | 128 |
| Total, serious adverse events | Diclectin® | 4 | 133 |
| Total, serious adverse events | Placebo | 5 | 128 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Diclectin® vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00614445
GET https://conductscience.org/api/trials/v1/NCT00614445/events?page=2