Trial Outcomes & Findings for Safety Evaluation of Aminophylline and Methazolamide (NCT NCT01587027)

NCT ID: NCT01587027

Last Updated: 2017-02-10

Results Overview

Adverse event data was evaluated for incidence and severity for 6 days.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

16 participants

Primary outcome timeframe

6 days.

Results posted on

2017-02-10

Participant Flow

The study proposed to randomize approximately 24 subjects to complete 16.

A total of 26 subjects were screened and consented. Of the subjects assessed, 21 (81%) passed and 5 (19%) were screen failures. Of those subjects who were screen failures, 3 (60%) had abnormal lab results and 2 (40%) had scheduling difficulties.

Participant milestones

Participant milestones
Measure	Sequence A Treatment 1, Treatment 2, Treatment 3 Treatment 1 : Aminophylline dosage form-tablet dosage-500mg Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally	Sequence B Treatment 2, Treatment 1, Treatment 3 Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally Treatment 2 : Methazolamide dosage form-tablet dosage-250mg
First Intervention (1 Day) STARTED	8	8
First Intervention (1 Day) COMPLETED	8	8
First Intervention (1 Day) NOT COMPLETED	0	0
Washout (1 Day) STARTED	8	8
Washout (1 Day) COMPLETED	8	8
Washout (1 Day) NOT COMPLETED	0	0
Second Intervention (1 Day) STARTED	8	8
Second Intervention (1 Day) COMPLETED	8	8
Second Intervention (1 Day) NOT COMPLETED	0	0
Third Intervention (1 Day) STARTED	8	8
Third Intervention (1 Day) COMPLETED	8	8
Third Intervention (1 Day) NOT COMPLETED	0	0
Discharge (1 Day) STARTED	8	8
Discharge (1 Day) COMPLETED	8	8
Discharge (1 Day) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Evaluation of Aminophylline and Methazolamide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence A n=8 Participants Treatment 1, Treatment 2, Treatment 3 Treatment 1 : Aminophylline dosage form-tablet dosage-500mg Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally	Sequence B n=8 Participants Treatment 2, Treatment 1, Treatment 3 Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally Treatment 2 : Methazolamide dosage form-tablet dosage-250mg	Total n=16 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=99 Participants	8 Participants n=107 Participants	16 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	25.60429 years STANDARD_DEVIATION 5.12602 • n=99 Participants	25 years STANDARD_DEVIATION 3.16228 • n=107 Participants	25.125 years STANDARD_DEVIATION 3.96443 • n=206 Participants
Gender Female	6 Participants n=99 Participants	2 Participants n=107 Participants	8 Participants n=206 Participants
Gender Male	2 Participants n=99 Participants	6 Participants n=107 Participants	8 Participants n=206 Participants
Region of Enrollment United States	8 participants n=99 Participants	8 participants n=107 Participants	16 participants n=206 Participants
BMI = <=18-30 kg/m2	8 Participants n=99 Participants	8 Participants n=107 Participants	16 Participants n=206 Participants

PRIMARY outcome

Timeframe: 6 days.

Population: All enrolled participants were analyzed for adverse events.

Adverse event data was evaluated for incidence and severity for 6 days.

Outcome measures

Outcome measures
Measure	Sequence A n=8 Participants Treatment 1, Treatment 2, Treatment 3 Treatment 1 : Aminophylline dosage form-tablet dosage-500mg Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally	Sequence B n=8 Participants Treatment 2, Treatment 1, Treatment 3 Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally Treatment 2 : Methazolamide dosage form-tablet dosage-250mg
Adverse Events.	29 Events	40 Events

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Gary Luckasen, M.D.

Medical Center of the Rockies

Phone: (970)624-1686

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Arm A n=8 participants at risk Aminophylline (1 Day) Washout (1 Day) Methazolamide (1 Day) Washout (1 Day) Both Aminophylline \& Methazolamide (1 Day) Discharge (1 Day)	Arm B n=8 participants at risk Methazolamide (1 Day) Washout (1 Day) Aminophylline (1 Day) Washout (1 Day) Both Aminophylline \& Methazolamide (1 Day) Discharge (1 Day)
Skin and subcutaneous tissue disorders Blister at IV site	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Skin and subcutaneous tissue disorders Bruising	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Decreased visual acuity	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Dizziness when standing	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Drunk feeling	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Skin and subcutaneous tissue disorders Facial tingling	25.0% 2/8 • Number of events 2 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Vascular disorders Flushing	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Headache	50.0% 4/8 • Number of events 6 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	62.5% 5/8 • Number of events 10 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Jitteriness	50.0% 4/8 • Number of events 6 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	87.5% 7/8 • Number of events 9 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Musculoskeletal and connective tissue disorders Lower back pain	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	12.5% 1/8 • Number of events 2 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Gastrointestinal disorders Nausea	25.0% 2/8 • Number of events 2 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	25.0% 2/8 • Number of events 3 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Numbness	25.0% 2/8 • Number of events 2 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Pain & edema to venipuncture site	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Pain at IV site	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Pressure in forearms	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Musculoskeletal and connective tissue disorders Shoulder stiffness	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Cardiac disorders Tachycardia	0.00% 0/8 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	12.5% 1/8 • Number of events 1 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Renal and urinary disorders Urinary Frequency	37.5% 3/8 • Number of events 3 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	50.0% 4/8 • Number of events 7 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.
Nervous system disorders Lightheadedness	25.0% 2/8 • Number of events 2 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.	12.5% 1/8 • Number of events 2 • 6 days per subject. Participants were monitored for adverse events during 6 days of study participation.