Drotaverine in Dysmenorrhoea Treatment

NCT00292747 | Terminated Phase 4

• 1 other identifier: L_9134
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea

Outcome Measures

Primary Outcomes (1)

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

Study Arms (3)

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

Drotaverine DRUG

Also known as: Z0124

Drotaverine + ibuprofen; drotaverine + Ibuprofen placebo

Drotaverine Placebo DRUG

Drotaverine placebo + ibuprofen

Ibuprofen DRUG

Drotaverine + ibuprofen; Drotaverine placebo + ibuprofen

Ibuprofen Placebo DRUG

drotaverine + Ibuprofen placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Budapest, Hungary

Location

MeSH Terms

Conditions

Dysmenorrhea

Interventions

drotaverin; Ibuprofen

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• László Erős, MD

  Sanofi-aventis, Hungary

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2006
• First Posted: February 16, 2006
• Study Start: May 25, 2005
• Primary Completion: February 28, 2006
• Study Completion: February 28, 2006
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

HU (1)