Trial Outcomes & Findings for Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients (NCT NCT00354484)
NCT ID: NCT00354484
Last Updated: 2018-02-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
291 participants
Primary outcome timeframe
anytime between baseline and end of study or time to intervention
Results posted on
2018-02-20
Participant Flow
Hospitals and medical clinics
1 subject in each group were discontinued from the study prior to dosing due to subject request.
Participant milestones
| Measure |
Ferric Carboxymaltose (FCM)
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
|
Ferrous Sulfate Tablets
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
147
|
|
Overall Study
COMPLETED
|
138
|
144
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of a Hematinic Agent in the Treatment of Postpartum Patients
Baseline characteristics by cohort
| Measure |
Ferric Carboxymaltose (FCM)
n=142 Participants
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
|
Ferrous Sulfate Tablets
n=147 Participants
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
|
Total
n=289 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
14 Participants
n=39 Participants
|
7 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
128 Participants
n=39 Participants
|
140 Participants
n=41 Participants
|
268 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
26.43 years
STANDARD_DEVIATION 6.02 • n=39 Participants
|
26.49 years
STANDARD_DEVIATION 5.55 • n=41 Participants
|
26.45 years
STANDARD_DEVIATION 5.86 • n=35 Participants
|
|
Sex: Female, Male
Female
|
142 Participants
n=39 Participants
|
147 Participants
n=41 Participants
|
289 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
142 participants
n=39 Participants
|
147 participants
n=41 Participants
|
289 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: anytime between baseline and end of study or time to interventionOutcome measures
| Measure |
Ferric Carboxymaltose (FCM)
n=142 Participants
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
|
Ferrous Sulfate Tablets
n=147 Participants
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
|
|---|---|---|
|
Number of Patients Classified as a 'Clinical Success'. Clinical Success Was Defined as the Number of Subjects With an Increase in Hemoglobin of >12 g/dL
|
127 participants
|
98 participants
|
PRIMARY outcome
Timeframe: anytime between baseline and end of study or time to interventionOutcome measures
Outcome data not reported
Adverse Events
Ferric Carboxymaltose (FCM)
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Ferrous Sulfate Tablets
Serious events: 4 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=142 participants at risk
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
|
Ferrous Sulfate Tablets
n=147 participants at risk
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.70%
1/142 • 7 months
|
0.00%
0/147 • 7 months
|
|
Cardiac disorders
Mitral valve prolapse
|
0.70%
1/142 • 7 months
|
0.00%
0/147 • 7 months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.70%
1/142 • 7 months
|
0.00%
0/147 • 7 months
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.70%
1/142 • 7 months
|
0.00%
0/147 • 7 months
|
|
Infections and infestations
Pyelonephritis
|
0.70%
1/142 • 7 months
|
0.00%
0/147 • 7 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/142 • 7 months
|
0.68%
1/147 • 7 months
|
|
Infections and infestations
Endometritis
|
0.00%
0/142 • 7 months
|
1.4%
2/147 • 7 months
|
|
Infections and infestations
Pelvic abscess
|
0.00%
0/142 • 7 months
|
1.4%
2/147 • 7 months
|
Other adverse events
| Measure |
Ferric Carboxymaltose (FCM)
n=142 participants at risk
Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
|
Ferrous Sulfate Tablets
n=147 participants at risk
325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
1.4%
2/142 • 7 months
|
12.2%
18/147 • 7 months
|
|
Nervous system disorders
Headache
|
4.9%
7/142 • 7 months
|
7.5%
11/147 • 7 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60