Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
70 participants
INTERVENTIONAL
2005-12-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Baclofen
The starting dose was 0.75 mg/kg in four divided doses daily and was cautiously increased at three-day intervals until crying subsided or symptoms of over dosage or side effects appeared. The usual maximum dose was two mg/kg in four divided doses daily.
Baclofen
Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.
placebo
Placebo contained fructose powder in equal quantity in packets mimicking those of Baclofen.
Placebo
Interventions
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Baclofen
Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age range 0-12 years.
Exclusion Criteria
* Crying that responded to routine management (changes in food or feeding techniques, anticolic, analgesics),
* Fever of ≥100.4ºF (38ºC),
* The infant refuses to eat or drink for more than a few hours, vomits excessively, has bloody stools, or has a change in behavior (lethargy or decreased responsiveness).
* Colic
* Worst ever crying occurring for the first time
* Respiratory, renal and hepatic diseases,
* Progressive encephalopathies,
* Received Baclofen in the previous 30 days
12 Years
ALL
No
Sponsors
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Sathbhavana Brain Clinic
OTHER
Responsible Party
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Dr.Nagabhushana Rao Potharaju
Principal Investigator
Principal Investigators
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Nagabhushana Rao Potharaju, BScDCHMDDM
Role: PRINCIPAL_INVESTIGATOR
Sathbhavana Brain Clinic, Secunderabad, India
Locations
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Sathbhavana Brain Clinic
Secunderabad, Andhra Pradesh, India
Countries
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Other Identifiers
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RCSCPSQ
Identifier Type: -
Identifier Source: org_study_id