Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-26 @ 4:46 AM
Study NCT ID:
NCT02242292
Status:
COMPLETED
Last Update Posted:
2017-12-28
First Post:
2014-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Efficacy and Safety of Oral Doses of Hyoscine Butylbromide for the Treatment of Occasional Abdominal Pain, Cramping, and Discomfort
Sponsor:
Boehringer Ingelheim
Organization:
Study Overview
Official Title:
A Double-blind, Placebo-controlled, Randomized, Parallel Group Study of the Efficacy and Safety of Oral Doses of 20 mg Hyoscine Butylbromide When Used On-demand up to 7 Episodes Over a Period of 6 Weeks for the Treatment of Occasional Episodes of Self-reported Abdominal Pain, Cramping, and Discomfort Associated With Cramping in an OTC-like Study Population
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study to determine whether hyoscine butylbromide can provide adequate symptomatic relief of a single episode - defined as lasting not longer than 1 day - and multiple episodes of abdominal pain or discomfort associated with cramping when used as needed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: