Hyoscine Butyl Bromide in Reducing Pain During HSG | NCT02709603

Studies
Hyoscine Butyl Bromide in Reducing Pain During HSG

NCT02709603

Sponsor

Assiut University

Status

Completed

Last Update Posted

Sep 7, 2016Estimated

Enrollment

200Actual

Phase

Phase 4

Conditions

Pain Relief With HSG

Interventions

hyoscine butyl bromide
placebo

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

May 2016Actual

Completion Date

Jun 2016Actual

First Submitted Date

Mar 11, 2016

First Submission Date that Met QC Criteria

Mar 11, 2016

First Posted Date

Mar 16, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure	Drug: hyoscine butyl bromide
Group B	Placebo Comparator	oral 2 tablets (PLACEBO) 30 minutes before the procedure	Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
hyoscine butyl bromide	Drug	oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mean pain score during. hysterosalpingography by visual analog scale		intraoperative

Secondary Outcomes

Measure	Description	Time Frame
Mean pain score after hysterosalpingography		30 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The infertile women who indicated for HSG.

Exclusion Criteria:

contraindications to Hyoscine or NSAID - known sensitivity to these drugs
known sensitivity to contrast media
abnormal uterine bleeding
genital tract infection
suspected pregnancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

42 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ahmed abbas, MD	Woman health hospital Assiut	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ahmed Abbas		Assiut	Cairo Governorate	002	Egypt
Ahmed Abbas

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002086	Butylscopolammonium Bromide

Ancestor Terms

ID	Term
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D012602	Scopolamine Derivatives

Browse Leaves

Not provided

Browse Branches

Not provided