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| ID | Type | Description | Link |
|---|---|---|---|
| 2004-000630-37 | EudraCT Number | ||
| 308601 |
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This study was designed as a proof-of-concept trial to evaluate safety, tolerability, and the efficacy of 1800 mg (ZK 811752 600 mg given orally three times daily) over 12 weeks for the treatment of endometriosis associated pelvic pain (EAPP) in comparison to placebo.
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCR-1 Receptor Antagonist | Experimental | Subjects received 600 mg (2 x 300 mg tablets) of CCR-1 Receptor Antagonist 3 times daily |
|
| Placebo | Placebo Comparator | Subjects received placebo corresponding to verum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCR1-Antagonist (BAY86-5047, ZK811752) | Drug | Given orally in a dose of 600 mg three times daily over 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Individual absolute change in endometriosis associated pelvic pain (EAPP) | EAPP was assessed by a composite parameter, consisting of the reading of the visual analog scale (VAS) and the intake of rescue medication | 12 weeks |
| Individual change in intake of rescue medication | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | 12 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hradec Králové | 50036 | Czechia | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37479520 | Derived | Sieverding M, Gerlinger C, Seitz C. Substituting a randomised placebo control group with a historical placebo control in an endometriosis pain trial: a case study re-evaluating trial data using historical control data from another trial. BMJ Open. 2023 Jul 21;13(7):e063188. doi: 10.1136/bmjopen-2022-063188. |
| Label | URL |
|---|---|
| Click here to find information about studies related to Bayer Healthcare products conducted in Europe. | View source |
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| Placebo | Drug | Placebo |
|
| Prague |
| 12851 |
| Czechia |
| Prague | 14700 | Czechia |
| Prague | 15006 | Czechia |
| Aarhus | 8200 | Denmark |
| Glostrup Municipality | 2600 | Denmark |
| Helsinki | 00029 | Finland |
| Helsinki | 00100 | Finland |
| Joensuu | 80210 | Finland |
| Kuopio | 70110 | Finland |
| Oulu | 90100 | Finland |
| Turku | 20100 | Finland |
| Bordeaux | France | 33000 | France |
| Clermont-Ferrand | 63000 | France |
| Lyon | 69003 | France |
| Amsterdam | 1061 AE | Netherlands |
| Amsterdam | 1081 HV | Netherlands |
| Maastricht | 6229 HX | Netherlands |
| Nijmegen | 6525 GA | Netherlands |
| Barcelona | Barcelona | 08036 | Spain |
| Madrid | Madrid | 28040 | Spain |
| Madrid | Madrid | 28046 | Spain |
| Oviedo | Principality of Asturias | 33006 | Spain |
| Valencia | Valencia | 46010 | Spain |
| Barcelona | 08022 | Spain |
| Seville | 41014 | Spain |
| Stockholm | Sweden | 182 88 | Sweden |
| Gothenburg | 41685 | Sweden |
| Lund | 22185 | Sweden |
| Skövde | 541 85 | Sweden |
| Stockholm | 141 86 | Sweden |
| Uppsala | 75185 | Sweden |
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C411885 | BX 471 |
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