Trial Outcomes & Findings for Haloperidol vs Conventional Therapy for Gastroparesis (NCT NCT02057549)

NCT ID: NCT02057549

Last Updated: 2017-08-17

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 36 participants
• Primary outcome timeframe: 1 hour after study medication given
• Results posted on: 2017-08-17

Participant Flow

Participant milestones

Measure	Haloperidol Plus Conventional Therapy Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Overall Study STARTED	18	18
Overall Study COMPLETED	15	18
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Measure	Haloperidol Plus Conventional Therapy Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Haloperidol vs Conventional Therapy for Gastroparesis

Baseline characteristics by cohort

Measure	Haloperidol Plus Conventional Therapy n=15 Participants Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy n=18 Participants Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Total n=33 Participants Total of all reporting groups
Age, Continuous	47 years n=5 Participants	45 years n=7 Participants	46 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	14 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour after study medication given

Outcome measures

Measure	Haloperidol Plus Conventional Therapy n=15 Participants Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy n=18 Participants Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication	11 Participants	5 Participants

SECONDARY outcome

Timeframe: 2 hours after study medication given

Outcome measures

Measure	Haloperidol Plus Conventional Therapy n=15 Participants Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy n=18 Participants Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Number of Participants Admitted to the Hospital After Emergency Department Visit	4 Participants	13 Participants

SECONDARY outcome

Timeframe: at the time the decision for final disposition is made (about 8 hours)

The "time frame" starts from the moment of receiving the study drug to the time when the decision for final disposition is made. Usually after symptoms are controlled, patients are given a PO challenge (food or drink) in order to establish if they are OK to go home. If symptoms return, additional medications are given, the treatment is consider failed and they are admitted to the Hospital.

Patients will not be followed up if admitted to any service. The study ends when final disposition is made.

Patients follow up after final disposition is not part of the study and will not be done.

Outcome measures

Measure	Haloperidol Plus Conventional Therapy n=15 Participants Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy n=18 Participants Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Emergency Department Length of Stay (EDLOS)	4.8 hours Interval 4.0 to 10.0	9 hours Interval 6.3 to 10.9

SECONDARY outcome

Timeframe: before study medication given

The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.

Outcome measures

Measure	Haloperidol Plus Conventional Therapy n=15 Participants Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy n=18 Participants Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Pain Score as Measured by a Visual Analogue Scale (VAS)	8.50 units on a scale Standard Deviation 1.82	8.28 units on a scale Standard Deviation 1.77

SECONDARY outcome

Timeframe: 1 hour after study medication given

The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.

Outcome measures

Measure	Haloperidol Plus Conventional Therapy n=15 Participants Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy n=18 Participants Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Pain Score as Measured by a Visual Analogue Scale (VAS)	3.13 units on a scale Standard Deviation 3.60	7.17 units on a scale Standard Deviation 2.81

SECONDARY outcome

Timeframe: before study medication given

The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.

Outcome measures

Measure	Haloperidol Plus Conventional Therapy n=15 Participants Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy n=18 Participants Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Nausea Score as Measured by a Visual Analogue Scale (VAS)	4.53 units on a scale Standard Deviation 0.83	4.11 units on a scale Standard Deviation 0.96

SECONDARY outcome

Timeframe: 1 hour after study medication given

The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.

Outcome measures

Measure	Haloperidol Plus Conventional Therapy n=15 Participants Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy n=18 Participants Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Nausea Score as Measured by a Visual Analogue Scale (VAS)	1.83 units on a scale Standard Deviation 1.92	3.39 units on a scale Standard Deviation 1.68

SECONDARY outcome

Timeframe: 1 hour after study medication given

Outcome measures

Measure	Haloperidol Plus Conventional Therapy n=15 Participants Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.	Conventional Therapy n=18 Participants Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication	11 Participants	13 Participants

Adverse Events

Haloperidol Plus Conventional Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Conventional Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Carlos J. Roldan MD

The University of Texas Houston Health Science Center

Phone: 713-792 6070

Email: croldan@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place