Trial Outcomes & Findings for Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea (NCT NCT00547898)
NCT ID: NCT00547898
Last Updated: 2020-09-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
374 participants
Primary outcome timeframe
31 days
Results posted on
2020-09-03
Participant Flow
Participant milestones
| Measure |
Placebo
Placebo: Placebo
|
Crofelemer 125 mg
Crofelemer 125 mg: Crofelemer 125 mg
|
Crofelemer 250 mg
Crofelemer 250 mg: Crofelemer 250 mg
|
Crofelemer 500 mg
Crofelemer 500 mg: Crofelemer 500 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
138
|
136
|
54
|
46
|
|
Overall Study
COMPLETED
|
129
|
126
|
54
|
40
|
|
Overall Study
NOT COMPLETED
|
9
|
10
|
0
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Effectiveness of 3 Doses of Crofelemer Compared to Placebo in the Treatment of HIV Associated Diarrhea
Baseline characteristics by cohort
| Measure |
Placebo
n=138 Participants
Placebo: Placebo
|
Crofelemer 125 mg
n=136 Participants
Crofelemer 125 mg: Crofelemer 125 mg
|
Crofelemer 250 mg
n=54 Participants
Crofelemer 250 mg: Crofelemer 250 mg
|
Crofelemer 500 mg
n=46 Participants
Crofelemer 500 mg: Crofelemer 500 mg
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.8 years
STANDARD_DEVIATION 8.42 • n=5 Participants
|
45 years
STANDARD_DEVIATION 7.66 • n=7 Participants
|
43.8 years
STANDARD_DEVIATION 8.37 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 9.06 • n=4 Participants
|
44.9 years
STANDARD_DEVIATION 1.59 • n=21 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
318 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 31 daysPopulation: The primary efficacy analysis was pre-specified to be for the optimal dose of crofelemer compared to placebo. Crofelemer 125 mg BID group was selected as the optimal dose. Since other doses of crofelemer were not considered to be the optimal dose, they are not included in the analysis.
Outcome measures
| Measure |
Crofelemer 125Mg BID
n=136 Participants
|
Placebo BID
n=138 Participants
|
Crofelemer 250 mg
Crofelemer 250 mg: Crofelemer 250 mg
|
Crofelemer 500 mg
Crofelemer 500 mg: Crofelemer 500 mg
|
|---|---|---|---|---|
|
Primary Efficacy Outcome is Count of Participants With Two or Less Watery Bowel Movements Per Week During at Least Two Weeks of the Treatment Phase of the Optimal Dose of Crofelemer Compared to Placebo
|
24 Participants
|
11 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 31 daysRelief of diarrhea was defined as two or less watery bowel movements per week during at least two weeks of the treatment phase.
Outcome measures
| Measure |
Crofelemer 125Mg BID
n=138 Participants
|
Placebo BID
n=136 Participants
|
Crofelemer 250 mg
n=54 Participants
Crofelemer 250 mg: Crofelemer 250 mg
|
Crofelemer 500 mg
n=46 Participants
Crofelemer 500 mg: Crofelemer 500 mg
|
|---|---|---|---|---|
|
Percentage of Participants Experiencing Relief of Diarrhea
|
11 Participants
|
24 Participants
|
5 Participants
|
9 Participants
|
Adverse Events
Placebo
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Crofelemer 125 mg
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Crofelemer 250 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Crofelemer 500 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=137 participants at risk
Placebo: Placebo
|
Crofelemer 125 mg
n=130 participants at risk
Crofelemer 125 mg: Crofelemer 125 mg
|
Crofelemer 250 mg
n=54 participants at risk
Crofelemer 250 mg: Crofelemer 250 mg
|
Crofelemer 500 mg
n=42 participants at risk
Crofelemer 500 mg: Crofelemer 500 mg
|
|---|---|---|---|---|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.73%
1/137
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/130
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/54
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/42
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/137
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.77%
1/130
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/54
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/42
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
|
Infections and infestations
PNEUMONIA
|
0.73%
1/137
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.77%
1/130
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/54
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/42
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFUSE LARGE B-CELL LYMPHOMA
|
0.73%
1/137
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/130
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/54
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/42
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.73%
1/137
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/130
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/54
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
0.00%
0/42
The safety population included participants who received study drug and had at least one post baseline assessment. The safety population was comprised of 226 crofelemer particpants and 137 placebo participants.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place