Phase 3
N=215
Efficacy and Safety Study of NPC-01 to Treat Dysmenorrhea
Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT01129102 ↗Enrolled (actual)
215
Serious AEs
0.5%
Results posted
Jun 2014
Primary outcome: Primary: Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) — 4.1; 4.2; 1.8; 2.9 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NPC-01 (Drug); IKH-01 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Nobelpharma
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Response to Treatment for Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment) |
4.1; 4.2; 1.8; 2.9 | — |
| SECONDARY Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-End of Treatment) |
51.8; 48.6; 21.2; 35.6 | — |
Summary
The purpose of this study is to determine whether NPC-01 is effective in the treatment of dysmenorrhea.
Eligibility Criteria
Inclusion Criteria
- dysmenorrhea
Exclusion Criteria
- severe hepatopathy
- pregnant woman
Data sourced from ClinicalTrials.gov (NCT01129102). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.