Trial Outcomes & Findings for A Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate. (NCT NCT01160198)
NCT ID: NCT01160198
Last Updated: 2018-04-13
Results Overview
At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
271 participants
Primary outcome timeframe
Baseline and Week 8
Results posted on
2018-04-13
Participant Flow
This study was conducted at 6 centers in India from 12-October-2010 to 17-February-2011. OROFER XT™ (ferrous ascorbate, 100 milligram \[mg\]) is a registered product of Emcure Pharmaceuticals Ltd., Pune and Ferronine™ (ferrous bisglycinate chelate, 60 mg) is registered product of GlaxoSmithKline.
A total of 317 participants with iron deficiency anaemia were screened for this study; of these, 270 participants were randomized. Intent-to-Treat (ITT) population: all randomized participants who received at least one dose of study medication (n=270). Before randomization, all participants were dewormed with a single tablet of 400 mg albendazole.
Participant milestones
| Measure |
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
|
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
|
Ferrous Ascorbate 100 mg 1 Once-daily
Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
89
|
91
|
90
|
|
Overall Study
COMPLETED
|
87
|
88
|
89
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
1
|
Reasons for withdrawal
| Measure |
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
|
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
|
Ferrous Ascorbate 100 mg 1 Once-daily
Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Participant lost drug; withdrew consent
|
0
|
0
|
1
|
Baseline Characteristics
A Study to Demonstrate the Efficacy and Tolerability of Ferrous Bisglycinate Chelate in Iron Deficiency Anaemia and to Compare These With Those of Ferrous Ascorbate.
Baseline characteristics by cohort
| Measure |
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
n=89 Participants
Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
|
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
n=91 Participants
Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
|
Ferrous Ascorbate 100 mg 1 Once-daily
n=90 Participants
Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
|
Total
n=270 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
India
|
89 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
270 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 8Population: Per protocol (PP) population.
At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Outcome measures
| Measure |
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
n=82 Participants
Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
|
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
n=83 Participants
Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
|
Ferrous Ascorbate 100 mg 1 Once-daily
Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
|
|---|---|---|---|
|
Change From Baseline in Hemoglobin (Hb) After 8 Weeks of Treatment in Each Ferrous Bisglycinate Chelate Group (1 Tablet Daily and 2 Tablets Daily)
|
2.6 Gram per deciliter (gm/dL)
Interval 2.12 to 3.03
|
2.8 Gram per deciliter (gm/dL)
Interval 2.36 to 3.31
|
—
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: PP population. Only those participants with data available at the indicated time points were analyzed.
At fortnightly visits, blood was collected for Hb. Baseline (Visit 0) was not more than 5 days from Week 1 or randomization. Change from Baseline was calculated by subtracting Baseline values from post-Baseline values.
Outcome measures
| Measure |
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
n=82 Participants
Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
|
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
n=83 Participants
Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
|
Ferrous Ascorbate 100 mg 1 Once-daily
n=87 Participants
Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
|
|---|---|---|---|
|
Mean Change in Hb From Baseline to 8 Weeks
|
2.6 gm/dL
Interval 2.12 to 3.03
|
2.8 gm/dL
Interval 2.36 to 3.31
|
2.6 gm/dL
Interval 2.19 to 3.09
|
SECONDARY outcome
Timeframe: Up to Week 8Population: PP population. Only those participants with data available at the indicated time points were analyzed.
At fortnightly visits, blood was collected for Hb. Number of participants who achieved a target Hb of more than or equal to 12 gm/dL is presented.
Outcome measures
| Measure |
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
n=82 Participants
Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
|
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
n=83 Participants
Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
|
Ferrous Ascorbate 100 mg 1 Once-daily
n=87 Participants
Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Achieved a Target Hb More Than or Equal to 12 gm/dL After 8 Weeks of Treatment
|
34.2 Percentage of participants
|
36.1 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 8Population: PP population. Only those participants available at the specified time points were analyzed.
At fortnightly visits, blood was collected for Hb. Mean change in Hb at Week 2, Week 4, Week 6 and Week 8 are presented.
Outcome measures
| Measure |
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
n=82 Participants
Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
|
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
n=83 Participants
Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
|
Ferrous Ascorbate 100 mg 1 Once-daily
n=87 Participants
Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
|
|---|---|---|---|
|
Mean Change in Hb During 8 Weeks Therapy
Week 8
|
2.6 gm/dL
Interval 2.12 to 3.03
|
2.8 gm/dL
Interval 2.36 to 3.31
|
2.6 gm/dL
Interval 2.19 to 3.09
|
|
Mean Change in Hb During 8 Weeks Therapy
Week 2
|
0.6 gm/dL
Interval 0.46 to 0.69
|
0.6 gm/dL
Interval 0.5 to 0.78
|
0.7 gm/dL
Interval 0.57 to 0.84
|
|
Mean Change in Hb During 8 Weeks Therapy
Week 4
|
1.2 gm/dL
Interval 0.98 to 1.45
|
1.3 gm/dL
Interval 1.07 to 1.61
|
1.4 gm/dL
Interval 1.1 to 1.61
|
|
Mean Change in Hb During 8 Weeks Therapy
Week 6
|
1.8 gm/dL
Interval 1.46 to 2.15
|
1.9 gm/dL
Interval 1.58 to 2.32
|
1.9 gm/dL
Interval 1.56 to 2.23
|
SECONDARY outcome
Timeframe: Up to Week 8Population: Intent to treat (ITT) population which comprised of all participants who received at least 1 dose of study drug.
The comparison in percentage of participants with gastrointestinal side effects during 8 week treatment period is reported. Gastrointestinal side effects during 8 weeks treatment included abdominal discomfort, gastritis, nausea, dyspepsia, change in bowel habit, constipation, faeces discolored, diarrhea and flatulence.
Outcome measures
| Measure |
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
n=89 Participants
Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
|
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
n=91 Participants
Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
|
Ferrous Ascorbate 100 mg 1 Once-daily
n=90 Participants
Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
|
|---|---|---|---|
|
Difference in Percentage of Participants With Gastrointestinal Side Effects During 8 Weeks Treatment With Ferrous Bisglycinate Chelate and Ferrous Ascorbate
|
6.7 Percentage of participants
|
9.9 Percentage of participants
|
11.1 Percentage of participants
|
Adverse Events
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Ferrous Ascorbate 100 mg 1 Once-daily
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ferrous Bisglycinate Chelate 60 mg 1 Once-daily
n=89 participants at risk
Participants received ferrous bisglycinate chelate, 1 tablet of 60 mg, once-daily after dinner, via oral route for 8 weeks.
|
Ferrous Bisglycinate Chelate 60 mg 1 Twice-daily
n=91 participants at risk
Participants received ferrous bisglycinate chelate, 1 tablet each of 60 mg, twice-daily after breakfast and dinner, via oral route for 8 weeks.
|
Ferrous Ascorbate 100 mg 1 Once-daily
n=90 participants at risk
Participants received ferrous ascorbate, 1 tablet of 100 mg once-daily after dinner, via oral route for 8 weeks.
|
|---|---|---|---|
|
General disorders
Pyrexia
|
1.1%
1/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
General disorders
Edema at the site of blood collection
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.1%
1/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Reproductive system and breast disorders
Menorrhagia
|
1.1%
1/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.1%
1/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
3/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
2.2%
2/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
4.4%
4/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
3.3%
3/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
3.3%
3/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
3.4%
3/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
2.2%
2/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Gastrointestinal disorders
Change in bowel habit
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Gastrointestinal disorders
Faeces discolored
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
2.2%
2/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/89 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
0.00%
0/91 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
1.1%
1/90 • Serious adverse events and non-serious adverse events data was collected from Week 2 (Visit 2) to Week 8 (end of study drug or Visit 5)
Serious adverse events and non-serious adverse events are reported for the Intent-to-Treat (ITT) population which comprised of all participants who were randomized and received at least one dose of the study medication
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER