Trial Outcomes & Findings for The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy (NCT NCT00614445)
NCT ID: NCT00614445
Last Updated: 2021-11-23
Results Overview
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).
COMPLETED
PHASE3
280 participants
Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)
2021-11-23
Participant Flow
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.
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.
Participant milestones
| Measure |
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®)
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
140
|
|
Overall Study
COMPLETED
|
112
|
91
|
|
Overall Study
NOT COMPLETED
|
28
|
49
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
Baseline characteristics by cohort
| Measure |
Diclectin®
n=140 Participants
Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
|
Placebo
n=140 Participants
Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
140 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.9 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
25.0 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
25.5 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
140 participants
n=5 Participants
|
140 participants
n=7 Participants
|
280 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) to End of Study Visit Day 15 (± 1 day)Population: Planned: Approximately 280 subjects (140 subjects per treatment group) were to be enrolled to achieve 200 evaluable subjects. Analyzed: 280 enrolled subjects \[261 subjects in the intent-to-treat safety (ITT-S) population; 256 subjects in the intent-to-treat efficacy (ITT-E) population\].
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).
Outcome measures
| Measure |
Diclectin®
n=140 Participants
Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
|
Placebo
n=140 Participants
Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
|
|---|---|---|
|
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).
|
-4.8 PUQE Score
Interval -5.26 to -4.34
|
-3.9 PUQE Score
Interval -4.36 to -3.44
|
Adverse Events
Diclectin®
Placebo
Serious adverse events
| Measure |
Diclectin®
n=133 participants at risk
Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
|
Placebo
n=128 participants at risk
Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Intra-uterine Death
|
0.75%
1/133 • Number of events 1
|
0.00%
0/128
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.00%
0/133
|
0.78%
1/128 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/133
|
0.78%
1/128 • Number of events 1
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/133
|
0.78%
1/128 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Premature rupture of membrane
|
0.00%
0/133
|
0.78%
1/128 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
Foetal disorder
|
0.00%
0/133
|
0.78%
1/128 • Number of events 1
|
Other adverse events
| Measure |
Diclectin®
n=133 participants at risk
Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
|
Placebo
n=128 participants at risk
Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
|
|---|---|---|
|
Gastrointestinal disorders
Adominal Pain
|
3.8%
5/133 • Number of events 5
|
6.2%
8/128 • Number of events 8
|
|
General disorders
Fatigue
|
6.8%
9/133 • Number of events 9
|
6.2%
8/128 • Number of events 8
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.3%
7/133 • Number of events 7
|
3.1%
4/128 • Number of events 4
|
|
Nervous system disorders
Dizziness
|
6.0%
8/133 • Number of events 8
|
6.2%
8/128 • Number of events 8
|
|
Nervous system disorders
Headache
|
12.8%
17/133 • Number of events 17
|
15.6%
20/128 • Number of events 20
|
|
Nervous system disorders
Somnolence
|
14.3%
19/133 • Number of events 19
|
11.7%
15/128 • Number of events 15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER