At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 299 enrolled
Drug / intervention
654-II (anisodamine) +1 moredrug
Likely dose
654-II (anisodamine) 10mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Independent 3rd Party Unblind, Active-controlled, Parallel-group, Multi-center Trial, in Contrast With Anisodamine (654-II), 10mg, to Evaluate the Efficacy and Safety of Buscopan® Solution for Injection, 20mg (Intramuscularly) for the Treatment of Acute Gastric or Intestinal Spasm-like Pain
In Brief
A Phase 3 clinical trial evaluating 654-II (anisodamine) and Buscopan® (hyoscine butylbromide) for Intestinal Diseases. Completed, enrolled 299 participants across 20 sites.
Detailed Summary
The aim of the study is to assess the efficacy of Buscopan® (hyoscine butylbromide) in comparison to 654-II (anisodamine)in acute gastric or intestinal spasm-like pain.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntestinal Diseases
CountriesChina
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedAug 2013
Primary CompletionFeb 2015
TodayJul 2026
First PostedAug 27, 2013
Enrollment StartAug 1, 2013
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 12.8 years ago
Interventions
654-II (anisodamine)drug
10mg injection
Buscopan® (hyoscine butylbromide)drug
20mg injection