Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on, Clinical Trial of NPC-01 for Treatment of Dysmenorrhea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01129102
• Other study ID #: NPC-01-2
• Status: Completed
• Phase: Phase 3
• First received: May 21, 2010
• Last updated: May 15, 2014
• Start date: May 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2014
• Source: Nobelpharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• dysmenorrhea

Exclusion Criteria:

• severe hepatopathy

• pregnant woman

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

Drug:
• NPC-01
Norethisterone 1mg, Ethinyl estradiol 0.02mg
• IKH-01
Norethisterone 1mg, Ethinyl estradiol 0.035mg
• Placebo
Placebo for NPC-01

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nobelpharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)	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	16weeks	No
Secondary	Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment)	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.	16weeks	No