A multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the safety, tolerability and efficacy of the CCR1 antagonist ZK 811752, given orally in a dose of 600 mg three times daily, for the treatment of endometriosis over 12 weeks.
- Conditions
- endometriosis associated pelvic pain
- Registration Number
- EUCTR2004-000630-37-CZ
- Lead Sponsor
- Schering AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 116
1. Signed and dated informed consent.
2. Women between 18 and 45 years of age, inclusive
3. Pain associated with visually proven endometriosis as determined by diagnostic laparoscopy or laparotomy within 24 months prior to start of treatment (Baseline, Visit 2) but no later than 6 weeks prior to Screening (Visit 1)
4. Threshold for pelvic pain score: minimum 40 mm on VAS at Screening (Visit 1) and at Baseline (Visit 2)
5. Women with cyclic menstrual bleeding
6. Normal cervical smear within the last 6 months according to PAP classification
7. Good general health (except for findings related to endometriosis, with or without infertility)
8. Willingness to use a barrier contraceptive method (unless bilateral tubal ligation has been performed previously), but no hormonal contraception
9. Willingness to use only up to 3 Ibuprofen 400 tablets as pain killer for endometriosis-associated pelvic pain
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Pregnancy, lactation (at least three cycles have to follow delivery, abortion or lactation before start of treatment)
2. Amenorrhea of more than 1 cycle within 3 months prior to study start
3. Bearing of an intra-uterine device (IUD, either hormonal or non-hormonal)
4. Signs and/or symptoms of therapy-resistent endometriosis despite various attempts of drug treatment or extensive surgical therapy
5. Need for primary surgical treatment of endometriosis according to the investigator
6. Previous / current use of hormonal agents including
-GnRH agonists and depot contraceptives within 6 cycles prior to screening
(Visit 1)
-Progestins and danazol within 3 cycles prior to screening (Visit 1)
-Hormonal contraception within 1 cycle prior to screening (Visit 1)
-Phytoestrogen intake must be stopped at screening (Visit 1)
7. Significant, incompletely-healed preexisting illnesses for which it can be assumed that absorption, distribution, metabolism, elimination, and effects of the investigational product will not be normal (e.g. gastrointestinal, autoimmune, signs for immune deficiency)
8. No actual or history of cardiovascular disorders
9. Family history of long QT-syndrome
10. Clinically relevant ECG findings, in particular prolonged QT interval (QT interval after Bazett’s correction for heart rate >440 msec and signs of ventricular hypertrophy at screening (Visit 1)
11. Abnormal baseline laboratory values that are beyond inclusion range, as defined by the Sponsor or that are considered clinically significant by the investigator
12. Conditions or medications that are prone to electrolyte changes (e.g. hypokalemia, hypomagnesemia)
13. Treatment with drugs that are potent inductors or inhibitors of CYP3A4 or drugs that are predominantly metabolised via CYP3A4, 2C9 or 2C19 and the increased plasma levels or prolonged action of which may lead to potentially serious side effects (see attachment no. 3 to the protocol)
14. Treatment with drugs that prolong the QT interval or increase the risk for hypokalemia (see attachment no. 3 to the protocol)
15. Intake of grapefruit or grapefruit juice
16. Clinically relevant findings at gynecological examination
17. History or suspicion of cancer or precancerous lesions of any type
18. Positive HIV test, positive hepatitis serology
19. Metabolic disturbances (particularly severe disturbances of lipid metabolism, insulin-dependent diabetes mellitus, uncontrolled thyroid disorders)
20. Vital signs (after resting for at least 10 minutes, sitting position)
-Systolic blood pressure > 140 mm Hg
-Diastolic blood pressure > 90 mm Hg
-Heart rate < 50 / min or heart rate > 100 / min
21. Known allergic reactions to constituents of the galenic formulation (Kollidon SR, lactose, fumaric acid, silicon dioxide, magnesium stearate, hydroxy propyl methyl cellulose, talcum, titanium dioxide and ferric oxide pigment), or to Ibuprofen
22. Wash out periods to be maintained before start of study medication:
? Less than 5 half life times following the treatment with drugs that may prolong the QT interval or increase the risk for hypokalemia or that are potent inductors or inhibitors of CYP3A4 or drugs that are predominantly metabolized via CYP3A4, 2C9, or 2C19 and the increased plasma levels or prolonged action of which may lead to potentially serìous side effects (see attachment)
? Less than two weeks following the use of chinidine and budipine and the first administration of the study drug
? Less than
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method