Drotaverine in Dysmenorrhoea Treatment

• Sponsor: Sanofi (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00292747
• Collaborator: (none)
• Enrollment: 480
• Location: 1
• Arms: 3
• Actual Duration (Months): 9.2
• Patients Per Site Per Month: 52.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dysmenorrhea	Drug: Drotaverine; Drug: Drotaverine Placebo; Drug: Ibuprofen; Drug: Ibuprofen Placebo	Phase 4

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Comparison of the Efficacy and Tolerability of Drotaverine 80 mg, Ibuprofen 400 mg and Their Combination in a Calendar Packaging for the Treatment of Primary and Secondary Dysmenorrhoea
• Actual Study Start Date: May 25, 2005
• Actual Primary Completion Date: Feb 28, 2006
• Actual Study Completion Date: Feb 28, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: drotaverine + Ibuprofen placebo Drotaverine 80 mg plus ibuprofen placebo orally	Drug: Drotaverine; Other Names: Z0124 ; Drug: Ibuprofen Placebo
Active Comparator: Drotaverine placebo + ibuprofen Drotaverine placebo plus ibuprofen 400 mg orally	Drug: Drotaverine Placebo; Drug: Ibuprofen
Active Comparator: Drotaverine + ibuprofen Drotaverine 80 mg plus ibuprofen 400 mg orally	Drug: Drotaverine; Other Names: Z0124 ; Drug: Ibuprofen

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis	Budapest		Hungary

Sponsors and Collaborators

• Sanofi

Investigators

• Study Director: László Erős, MD, Sanofi-aventis, Hungary

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanofi
• ClinicalTrials.gov Identifier: NCT00292747
• Other Study ID Numbers: L_9134
• First Posted: Feb 16, 2006
• Last Update Posted: Aug 8, 2017
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Dysmenorrhea; Ibuprofen; Drotaverin; Papaverine

Study Results

No Results Posted as of Aug 8, 2017