Trial record 2 of 37 for:    PDC

Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PDC Biotech GmbH
ClinicalTrials.gov Identifier:
NCT01250587
First received: November 29, 2010
Last updated: September 20, 2012
Last verified: September 2012

November 29, 2010
September 20, 2012
November 2010
June 2012   (final data collection date for primary outcome measure)
Occurrence of Dose-Limiting Toxicity [ Time Frame: Observed following PDC31 administration to 30 day follow-up ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01250587 on ClinicalTrials.gov Archive Site
Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility [ Time Frame: Observed immediately following PDC31 administration ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea
A Dose-Escalating Phase I Study to Evaluate the Safety, Pharmacokinetics and Efficacy of PDC31 in Patients With Primary Dysmenorrhea

The purpose of this study is to determine a safe and effective dose range for intravenous administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in patients with primary dysmenorrhea.

This is an open-label, multi-centre, dose-escalating first-in-human Phase I study of PDC31 in patients with primary dysmenorrhea aimed at determining the maximum tolerated dose (MTD) of PDC31 in this patient population.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dysmenorrhea
Drug: PDC31
This study involves the sequential administration of PDC31 to 4 cohorts of patients. The dose will be escalated in the absence of dose-limiting toxicities. PDC31 is to be administered as a 3-hour continuous infusion.
Experimental: PDC31
Intervention: Drug: PDC31
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Otherwise healthy females with a history of primary dysmenorrhea
  • Using effective birth control excluding intrauterine contraceptive device (IUCD)
  • Must be 18 years of age or older
  • Must give written informed consent to participate in this study

Exclusion Criteria:

  • Patients with an intrauterine contraceptive device or using oral contraceptives within 3 months of treatment in this study
  • Patients with confirmed pelvic inflammatory disease, endometriosis or adenomyosis
  • Patients who are pregnant or who test positive at baseline or are at risk of becoming pregnant while on study
  • Patients who are breastfeeding
  • Patients with hepatic or renal function tests greater than the upper limit of normal and deemed clinically significant by the Investigator at screening
  • Patients with a clinically significant medical or psychiatric disorder or a serious medical conditions within the past 6 months which in the opinion of the investigator, should prohibit participation in this study
  • Patients who have been exposure to any investigational drug within 4 weeks prior to screening
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT01250587
PDC-3111
Yes
PDC Biotech GmbH
PDC Biotech GmbH
Not Provided
Not Provided
PDC Biotech GmbH
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP