Trial Outcomes & Findings for Phase IIIb Study of APD421 in Combination as PONV Prophylaxis (NCT NCT02337062)
NCT ID: NCT02337062
Last Updated: 2019-03-20
Results Overview
Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1147 participants
Primary outcome timeframe
24 hours after the end of surgery
Results posted on
2019-03-20
Participant Flow
Study start date:- 12th February 2015 (first patient in) Study completion date:- 28th September 2015 (last patient last visit) Location:-France, Germany and the USA.
Participant milestones
| Measure |
APD421 + Standard Anti-emetic
APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
|
Placebo + Standard Anti-emetic
Matching Placebo administered as a single, slow push, IV push over one minute at the time of induction anaesthesia given in combination with standard anti-emetic
|
|---|---|---|
|
Overall Study
STARTED
|
572
|
575
|
|
Overall Study
COMPLETED
|
555
|
556
|
|
Overall Study
NOT COMPLETED
|
17
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase IIIb Study of APD421 in Combination as PONV Prophylaxis
Baseline characteristics by cohort
| Measure |
APD421 + Standard Anti-emetic
n=572 Participants
Single dose of IV APD421
APD421
|
Placebo + Standard Anti-emetic
n=575 Participants
Single dose of IV placebo
Placebo
|
Total
n=1147 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.8 Years
STANDARD_DEVIATION 14.24 • n=5 Participants
|
48.3 Years
STANDARD_DEVIATION 13.98 • n=7 Participants
|
48.5 Years
STANDARD_DEVIATION 14.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
552 Participants
n=5 Participants
|
557 Participants
n=7 Participants
|
1109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
353 Participants
n=5 Participants
|
351 Participants
n=7 Participants
|
704 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
79 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
140 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hours after the end of surgeryPopulation: Modified intent-to-treat
Complete response defined as no emesis and no use of rescue medication in the 24 hour period after end of surgery (defined as wound closure)
Outcome measures
| Measure |
APD421 5mg + Standard Anti-emetic
n=572 Participants
APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
|
Placebo + Standard Anti-emetic
n=575 Participants
Matching placebo administered as a single, slow, IV push over one minute, at the time of induction of anaesthesia; given in combination with standard anti-emetic
|
|---|---|---|
|
Number of Participants With Complete Response
|
330 Participants
|
268 Participants
|
SECONDARY outcome
Timeframe: 24 hours after the end of surgeryEmesis is defined as vomiting (production of even the smallest amount of stomach contents) or retching (muscular movements of vomiting but without expulsion of stomach contents, usually because of an empty stomach)
Outcome measures
| Measure |
APD421 5mg + Standard Anti-emetic
n=572 Participants
APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
|
Placebo + Standard Anti-emetic
n=575 Participants
Matching placebo administered as a single, slow, IV push over one minute, at the time of induction of anaesthesia; given in combination with standard anti-emetic
|
|---|---|---|
|
Number of Participants With Emesis
|
79 Participants
|
115 Participants
|
SECONDARY outcome
Timeframe: 24 hours after the end of surgeryRescue medication defined as an antiemetic (or other medication) given with the intention of relieving nausea and/or emesis, or any incidental use of a drug known to have antiemetic potential
Outcome measures
| Measure |
APD421 5mg + Standard Anti-emetic
n=572 Participants
APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
|
Placebo + Standard Anti-emetic
n=575 Participants
Matching placebo administered as a single, slow, IV push over one minute, at the time of induction of anaesthesia; given in combination with standard anti-emetic
|
|---|---|---|
|
Number of Participants Receiving Rescue Medication
|
234 Participants
|
284 Participants
|
SECONDARY outcome
Timeframe: 24 hours after the end of surgeryNausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Any nausea" means a score ≥ 1.
Outcome measures
| Measure |
APD421 5mg + Standard Anti-emetic
n=572 Participants
APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
|
Placebo + Standard Anti-emetic
n=575 Participants
Matching placebo administered as a single, slow, IV push over one minute, at the time of induction of anaesthesia; given in combination with standard anti-emetic
|
|---|---|---|
|
Number of Participants With Any Nausea
|
286 Participants
|
335 Participants
|
SECONDARY outcome
Timeframe: 24 hours after end of surgeryNausea (defined as the desire to vomit without the presence of expulsive muscular movements) measured on a 0-10 verbal response scale, where 0=no nausea at all and 10=the worst nausea imaginable. "Significant nausea" means a score ≥ 4.
Outcome measures
| Measure |
APD421 5mg + Standard Anti-emetic
n=572 Participants
APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
|
Placebo + Standard Anti-emetic
n=575 Participants
Matching placebo administered as a single, slow, IV push over one minute, at the time of induction of anaesthesia; given in combination with standard anti-emetic
|
|---|---|---|
|
Number of Participants With Significant Nausea
|
212 Participants
|
274 Participants
|
SECONDARY outcome
Timeframe: 24 hours after end of surgeryCriteria for PONV are any episode of emesis or use of rescue medication in the 24 hours after the end of surgery
Outcome measures
| Measure |
APD421 5mg + Standard Anti-emetic
n=572 Participants
APD421 (amisulpride) at 5 mg administered as a single, slow, intravenous (IV) push over one minute at the time of induction of anaesthesia; given in combination with standard anti-emetic.
|
Placebo + Standard Anti-emetic
n=575 Participants
Matching placebo administered as a single, slow, IV push over one minute, at the time of induction of anaesthesia; given in combination with standard anti-emetic
|
|---|---|---|
|
Time to First Violation of Criteria for PONV
|
NA minutes
Interval 195.5 to
Median value not available as \<50% of participants met criteria for PONV. Upper bound of IQR not available as \<75% of participants met criteria for PONV.
|
821.0 minutes
Interval 107.0 to
Upper bound of IQR not available as \<75% of participants met criteria for PONV.
|
Adverse Events
APD421 + Standard Anti-emetic
Serious events: 14 serious events
Other events: 111 other events
Deaths: 1 deaths
Placebo + Standard Anti-emetic
Serious events: 14 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
APD421 + Standard Anti-emetic
n=572 participants at risk
Single dose of IV APD421
APD421
|
Placebo + Standard Anti-emetic
n=575 participants at risk
Single dose of IV placebo
Placebo
|
|---|---|---|
|
Injury, poisoning and procedural complications
Post Procedural haemorrhage
|
0.35%
2/572 • Number of events 2 • For the 7 day period after study drug administration
|
0.35%
2/575 • Number of events 2 • For the 7 day period after study drug administration
|
|
Injury, poisoning and procedural complications
Wound Secretion
|
0.17%
1/572 • Number of events 1 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
|
Injury, poisoning and procedural complications
Herpatic Haematoma
|
0.00%
0/572 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
|
Injury, poisoning and procedural complications
Pelvic Organ Injury
|
0.17%
1/572 • Number of events 1 • For the 7 day period after study drug administration
|
0.00%
0/575 • For the 7 day period after study drug administration
|
|
Injury, poisoning and procedural complications
Postoerative ileus
|
0.00%
0/572 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
|
Injury, poisoning and procedural complications
Procedural Haemorrhage
|
0.00%
0/572 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.17%
1/572 • Number of events 1 • For the 7 day period after study drug administration
|
0.00%
0/575 • For the 7 day period after study drug administration
|
|
Infections and infestations
Peritonitis
|
0.35%
2/572 • Number of events 2 • For the 7 day period after study drug administration
|
0.00%
0/575 • For the 7 day period after study drug administration
|
|
Infections and infestations
Pneumonia
|
0.17%
1/572 • Number of events 1 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
|
Infections and infestations
Post Operative wound infections
|
0.35%
2/572 • Number of events 2 • For the 7 day period after study drug administration
|
0.00%
0/575 • For the 7 day period after study drug administration
|
|
Infections and infestations
Gastroenteritis viral
|
0.17%
1/572 • Number of events 1 • For the 7 day period after study drug administration
|
0.00%
0/575 • For the 7 day period after study drug administration
|
|
Infections and infestations
Sepsis
|
0.17%
1/572 • Number of events 1 • For the 7 day period after study drug administration
|
0.00%
0/575 • For the 7 day period after study drug administration
|
|
Infections and infestations
Staphylococcal infections
|
0.00%
0/572 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/572 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
|
Infections and infestations
Wound infection
|
0.00%
0/572 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
|
Gastrointestinal disorders
Small intestinal Obstruction
|
0.17%
1/572 • Number of events 1 • For the 7 day period after study drug administration
|
0.35%
2/575 • Number of events 2 • For the 7 day period after study drug administration
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.17%
1/572 • Number of events 1 • For the 7 day period after study drug administration
|
0.00%
0/575 • For the 7 day period after study drug administration
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/572 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/572 • For the 7 day period after study drug administration
|
0.17%
1/575 • Number of events 1 • For the 7 day period after study drug administration
|
Other adverse events
| Measure |
APD421 + Standard Anti-emetic
n=572 participants at risk
Single dose of IV APD421
APD421
|
Placebo + Standard Anti-emetic
n=575 participants at risk
Single dose of IV placebo
Placebo
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
10.8%
62/572 • Number of events 62 • For the 7 day period after study drug administration
|
12.2%
70/575 • Number of events 70 • For the 7 day period after study drug administration
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
9.3%
53/572 • Number of events 53 • For the 7 day period after study drug administration
|
10.1%
58/575 • Number of events 58 • For the 7 day period after study drug administration
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60