Drotaverine in Dysmenorrhoea Treatment | NCT00292747

Studies
Drotaverine in Dysmenorrhoea Treatment

NCT00292747

Sponsor

Sanofi

Status

Terminated

Last Update Posted

Aug 8, 2017Actual

Enrollment

480

Phase

Phase 4

Conditions

Dysmenorrhea

Interventions

Drotaverine
Drotaverine Placebo
Ibuprofen
Ibuprofen Placebo

Countries

Hungary

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

Aug 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

early termination due to loss of interest and low enrollment of patient

Expanded Access Info

Start Date

May 25, 2005Actual

Primary Completion Date

Feb 28, 2006Actual

Completion Date

Feb 28, 2006Actual

First Submitted Date

Feb 15, 2006

First Submission Date that Met QC Criteria

Feb 15, 2006

First Posted Date

Feb 16, 2006Estimated

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

Aug 4, 2017

Last Update Posted Date

Aug 8, 2017Actual

Description Module

Brief Summary

The aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered alone, in the treatment of primary and secondary dysmenorrhoea.

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

480

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
drotaverine + Ibuprofen placebo	Experimental	Drotaverine 80 mg plus ibuprofen placebo orally	Drug: Drotaverine Drug: Ibuprofen Placebo
Drotaverine placebo + ibuprofen	Active Comparator	Drotaverine placebo plus ibuprofen 400 mg orally	Drug: Drotaverine Placebo Drug: Ibuprofen
Drotaverine + ibuprofen	Active Comparator	Drotaverine 80 mg plus ibuprofen 400 mg orally	Drug: Drotaverine Drug: Ibuprofen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Drotaverine	Drug		Drotaverine + ibuprofen drotaverine + Ibuprofen placebo	Z0124

Measure	Description	Time Frame
Reponse rate in each treatment arm: proportion of patients having pain intensity score 0 or 1 at hour 2 after the first drug intake.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

History of at least 6 months of dysmenorrhea, with presence of moderate to severe pain in each of the last 3 cycles
With regular menstrual cycles (25-35 days)
Using an adequate barrier contraception method (except for virgins)

Exclusion Criteria:

Evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations
Proven hypersensitivity to drotaverine hydrochloride or ibuprofen or proven intolerance to lactose
Any described contraindication to either drotaverine hydrochloride or ibuprofen (see Summary of Product Characteristics)
Oestro-progestative contraception within the last 2 months
Regular use of sedative, hypnotics, tranquillizers or any other addictive agents
History or evidence of acute or chronic alcohol abuse
Heavy smoking (> 10 cigarettes/day)
Need of a permanent treatment with other antispasmodics and/or analgesic agents during the trial
Lactation
Pregnancy
Participation in another clinical trial in the last 3 months prior to the start of this study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008599	Menstruation Disturbances
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D017699	Pelvic Pain

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

ID	Term
C005317	drotaverin
D007052	Ibuprofen