parallel randomized trial

S002941

Other conditionsS002941

Design

Randomized: 15
Start year: 2017
Treatment: 12 weeks, follow-up 12 weeks
Countries: United Kingdom (1 sites)
Sponsor: (mixed)
Eligibility: women 18 to 60 years; active IIH with papilledema; ICP above 25 cmCSF

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: pharmacy or sealed
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: none

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Exenatide 10 ug subcutaneous twice daily Exenatide 10 ug twice daily	lifestyle: not reported	7	7
A2	Placebo Placebo	lifestyle: not reported	8	8

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Exenatide 10 ug subcutaneous twice daily A1	Placebo A2	Whole trial ALL
age	mean (years)	28	28
age	sd (years)	13	6
bmi	mean (kg/m2)	37.6	38.6
bmi	sd (kg/m2)	7.9	4.7
female	n			15

Results

40 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

SF-36 physical component summary change (3 lines; O24A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
12	A1	change	4.1 points	7.4	-2.7 to 10.9	7	not stated; randomized; R0011288:Supplement Table S4
12	A1 vs A2	md	-5.7 points	9.5	-24.3 to 12.9		not stated; randomized; R0011288:Supplement Table S4
12	A2	change	1.7 points	9.5	-6.2 to 9.6	8	not stated; randomized; R0011288:Supplement Table S4

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Results
	A2	events				1 / 8	not stated; randomized; R0011288:Results

Discontinuation due to adverse events (2 lines; O26)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Results
	A2	events				0 / 8	not stated; randomized; R0011288:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	7 / 7	not stated; randomized; R0011288:Discussion
A2	events	0 / 8	not stated; randomized; R0011288:Supplement Table S8
A2	events	0 / 8	not stated; randomized; R0011288:Supplement Table 8

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Results
	A2	events				0 / 8	not stated; randomized; R0011288:Results

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Medullary thyroid carcinoma (2 lines; O32A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Thyroid cancer (any) (2 lines; O32B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Nonarteritic anterior ischemic optic neuropathy (2 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Suicidal ideation or behavior (2 lines; O35A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Results
	A2	events				0 / 8	not stated; randomized; R0011288:Results

Gastroparesis (2 lines; O37A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Intestinal obstruction or ileus (2 lines; O37B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Pancreatic cancer (2 lines; O38)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8

Any cancer (2 lines; O39)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 7	not stated; randomized; R0011288:Supplement Table S8
	A2	events				0 / 8	not stated; randomized; R0011288:Supplement Table S8