Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01129102
Recruitment Status : Completed
First Posted : May 24, 2010
Results First Posted : June 17, 2014
Last Update Posted : June 17, 2014
Sponsor:
Information provided by (Responsible Party):
Nobelpharma

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

Condition or disease Intervention/treatment Phase
Dysmenorrhea Drug: NPC-01 Drug: IKH-01 Drug: Placebo Phase 3

Detailed Description:

The main objective of this study is to confirm the effectiveness and safety profile of NPC-01 in comparison with placebo in the treatment of dysmenorrhea (primary and secondary dysmenorrhea).

Additionally we also investigate the differences of effectiveness of NPC-01 in comparison with IKH-01 in the treatment of secondary dysmenorrhea as a reference, because IKH-01 is already marketed at them.

To achieve these, closed testing procedure is used in this study. After confirming statistical differences between NPC-01 and Placebo in the total dysmenorrhea, stratified analysis is carried out for primary dysmenorrhea (NPC-01, Placebo), and secondary dysmenorrhea (NPC-01, IKH-01 and Placebo).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea
Study Start Date : May 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Experimental: NPC-01
Norethisterone 1mg, Ethinyl estradiol 0.02mg
Drug: NPC-01
Norethisterone 1mg, Ethinyl estradiol 0.02mg

Active Comparator: IKH-01
Norethisterone 1mg, Ethinyl estradiol 0.035mg
Drug: IKH-01
Norethisterone 1mg, Ethinyl estradiol 0.035mg

Placebo Comparator: Placebo
Placebo for NPC-01
Drug: Placebo
Placebo for NPC-01




Primary Outcome Measures :
  1. Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) [ Time Frame: 16weeks ]

    The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work

    Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days



Secondary Outcome Measures :
  1. Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) [ Time Frame: 16weeks ]
    VAS stands for Visual Analogue Scale of pain. The scale was rated as a graphic rating scale. as a 100mm baseline from 0:No pain to 100:Worst possible pain.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • dysmenorrhea

Exclusion Criteria:

  • severe hepatopathy
  • pregnant woman

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01129102


Sponsors and Collaborators
Nobelpharma
Investigators
Layout table for investigator information
Study Director: Naoki Terakawa, M.D.,Ph.D. Nissay Hospital,Osaka,Japan
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Nobelpharma
ClinicalTrials.gov Identifier: NCT01129102    
Other Study ID Numbers: NPC-01-2
First Posted: May 24, 2010    Key Record Dates
Results First Posted: June 17, 2014
Last Update Posted: June 17, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations