Clinical trial
Treatment of Orthostatic Intolerance
Name
008397
Description
This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
Trial arms
Trial start
1997-04-01
Estimated PCD
2025-12-01
Trial end
2025-12-01
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Acetazolamide
250 mg PO x 1
Arms:
1
Other names:
Diamox
Atomoxetine
10-40 mg PO x 1 dose
Arms:
2
Other names:
Strattera
NO Drug
No intervention - just monitoring
Arms:
3
Clonidine
Clonidine 0.05-0.3 mg PO x 1 dose
Arms:
4
Other names:
Catapres
Entacapone
Entacapone 200-400 mg PO x 1 dose
Arms:
5
Other names:
Comtan
Entacapone & Propranolol
Entacapone 200-400 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Arms:
15, 5
Other names:
Comtan, Inderal
Atomoxetine & Propranolol
Atomoxetine 10-40 mg PO x 1 dose AND propranolol 20 mg PO x 1 dose
Arms:
15, 2
Other names:
Strattera, Inderal
Indomethacin
Indomethacin 25-50 mg PO x 1 dose
Arms:
6
Other names:
Indocin
Mecamylamine
mecamylamine 1.25-5 mg PO x 1 dose
Arms:
8
Other names:
inversine
Isosorbide Dinitrate
Isosorbide dinitrate 5-20 mg PO x 1 dose
Arms:
7
Other names:
Isordil
Melatonin
melatonin 3 mg PO x 1 dose
Arms:
10
Midodrine
midodrine 2.5-10 mg PO x 1 dose
Arms:
11
Other names:
pro-amatine
Modafinil
modafinil 100-200 mg PO x 1 dose
Arms:
12
Other names:
provigil
Octreotide
octreotide 12.5-50 mcg Subcutaneous x 1 dose
Arms:
13
Other names:
sandostatin
Placebo
lactose tablet x 1 pill
Arms:
14
Propranolol
Propranolol 10-80 mg PO x 1-2 dose
Arms:
15
Other names:
Inderal
Modafinil & Propranolol
Modafinil 100-200 mg PO x 1 dose AND Propranolol 20 mg PO x 1 dose
Arms:
12, 15
Other names:
Provigil, Inderal
Sertraline
sertraline 25-50 mg PO x 1 dose
Arms:
16
Other names:
Zoloft
IV Saline
1 liter IV over 2 hours
Arms:
17
Other names:
NaCl solution (0.9%)
Drinking Water
16 fluid ounces
Arms:
18
Breathing Device
Breathing through a dead space tube
Arms:
19
memantine
memantine 5-20 mg PO x 1 dose
Arms:
9
Other names:
Namenda
Abdominal binder
Using large blood pressure cuffs linked together, they are wrapped around the subjects abdomen and inflated to generate increased pressure to below tolerably threshold.
Arms:
Abdominal Binder
Size
150
Primary endpoint
Increase in heart rate with standing
1-4 hours
Eligibility criteria
Inclusion Criteria:
* Chronic symptoms (\> 6 months) with standing upright
Exclusion Criteria:
* Obvious cause of hypovolemia or drugs that could worsen tachycardia
* Chronic severe medical conditions such as cancer or ischemic heart disease
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 150, 'type': 'ESTIMATED'}}
Updated at
2023-09-22
1 organization
16 products
2 indications
Organization
Satish R. RajProduct
AcetazolamideIndication
TachycardiaIndication
Chronic Orthostatic IntoleranceProduct
AtomoxetineProduct
ClonidineProduct
EntacaponeProduct
Entacapone + PropranololProduct
Atomoxetine & PropranololProduct
IndomethacinProduct
MecamylamineProduct
Isosorbide DinitrateProduct
MidodrineProduct
ModafinilProduct
OctreotideProduct
PropranololProduct
Modafinil & PropranololProduct
SertralineProduct
memantine