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Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nobelpharma
ClinicalTrials.gov Identifier:
NCT01129102
First received: May 21, 2010
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.


Condition Intervention Phase
Dysmenorrhea
 Drug: NPC-01
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase3,Placebo Controlled,Randomized,Double-Blinded,NSAID-Add-on,Clinical Trial of NPC-01 for Treatment of Dysmenorrhea

Further study details as provided by Nobelpharma:

Primary Outcome Measures:
  • Measure: patient response to treatment for dysmenorrhea ,as evaluated by VRS [ Time Frame: 16weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: change in the VAS of dysmenorrhea [ Time Frame: 16weeks ] [ Designated as safety issue: No ]

Enrollment: 215
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NPC-01 Drug: NPC-01
Norethindrone,Ethinyl Estradiol
Active Comparator: IKH-01 Drug: NPC-01
Norethindrone,Ethinyl Estradiol
Placebo Comparator: Placebo Drug: NPC-01
Norethindrone,Ethinyl Estradiol

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dysmenorrhea

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01129102

Sponsors and Collaborators
Nobelpharma
Investigators
Study Director: Naoki Terakawa, M.D.,Ph.D. Nissay Hospital,Osaka,Japan
  More Information

No publications provided

Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT01129102     History of Changes
Other Study ID Numbers: NPC-01-2
Study First Received: May 21, 2010
Last Updated: April 26, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
 Pelvic Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013