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EudraCT Number: 2008-005127-29

Sponsor Protocol Number: TAX_GMA_302

Start Date: 2001-05-21

Sponsor Name: SANOFI-AVENTIS

Full Title: MULTICENTER PHASE III RANDOMIZED TRIAL COMPARING DOXORUBICIN AND CYCLOPHOSPHAMIDE FOLLOWED BY DOCETAXEL (AC->T) WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOLLOWED BY DOCETAXEL AND TRASTUZUMAB (HERCEPTI...

Medical condition: node positive and high risk node negative patients with operable breast cancer containing the the HER2 alteration.

Disease:	Version	SOC Term	Classification Code	Term	Level
	9.1		10057654	Breast cancer female	LLT

Population Age: Adults, Elderly

Gender: Female

Trial protocol: HU (Completed) SK (Completed)

Trial results: View results

EudraCT Number: 2004-000238-36

Sponsor Protocol Number: IST-399

Start Date: 1999-10-05

Sponsor Name: The University of Edinburgh & Lothian Health Board

Full Title: Third International Stroke Trial (IST-3) of thrombolysis for acute ischaemic stroke

Medical condition: Acute ischaemic stroke refers to strokes caused by thrombosis or embolism and accounts for 85% of all strokes.

Disease:	Version	SOC Term	Classification Code	Term	Level
	9.1		10023027	Ischaemic stroke NOS	LLT

Population Age: Adults, Elderly

Gender: Male, Female

Trial protocol: GB (Completed) PT (Completed)

Trial results: View results

EudraCT Number: 2009-018118-21

Sponsor Protocol Number: OXN2503

Start Date:

Sponsor Name: Mundipharma Research GmbH & Co. KG

Full Title: An exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic efficacy of oxycodone/naloxone prolonged release tablets (OXN PR) compared to place...

Medical condition: Bladder Pain Syndrome (BPS), formerly addressed as IC/PBS (interstitial cystitis /Painful Bladder Syndrome)

Disease:	Version	SOC Term	Classification Code	Term	Level
	14.1	100000004857	10008927	Chronic interstitial cystitis	LLT

Population Age: Adults, Elderly

Gender: Female

Trial protocol: DE (Completed) HU (Completed) CZ (Completed) GB (Completed)

Trial results: View results

EudraCT Number: 2018-003673-10

Sponsor Protocol Number: AV003

Start Date:

Sponsor Name: Bond Avillion 2 Development LP

Full Title: A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in S...

Medical condition: Moderate to severe asthma

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.1	100000004855	10015575	Exacerbation of asthma	LLT
	21.0	100000004855	10003561	Asthma, unspecified	LLT

Population Age: Children, Adolescents, Under 18, Adults, Elderly

Gender: Male, Female

Trial protocol: DE (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) SK (Completed) ES (Completed) IT (Ongoing)

Trial results: (No results available)

EudraCT Number: 2020-002951-39

Sponsor Protocol Number: CAAA601A32201

Start Date:

Sponsor Name: Advanced Accelerator Applications SA

Full Title: A multicenter open-label study to evaluate safety and dosimetry of Lutathera in adolescent patients with somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheoc...

Medical condition: somatostatin receptor positive gastroenteropancreatic neuroendocrine (GEP-NET) tumors, pheochromocytoma and paragangliomas

Disease:	Version	SOC Term	Classification Code	Term	Level
	21.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10052399	Neuroendocrine tumour	PT
	20.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10077559	Gastroenteropancreatic neuroendocrine tumour disease	PT
	20.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10077560	Gastroenteropancreatic neuroendocrine tumor disease	LLT
	20.1	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10034876	Pheochromocytoma	LLT
20.0	10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)	10073860	Paraganglioma	LLT

Population Age: Adolescents, Under 18

Gender: Male, Female

Trial protocol: SE (Prematurely Ended) FR (Ongoing) PT (Ongoing) PL (Ongoing) BE (Completed) IT (Ongoing) NL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2012-005325-67

Sponsor Protocol Number: 1239102

Start Date:

Sponsor Name: Centre Hospitalier de Toulouse

Full Title: Evaluation of tolerance, suckling and food intake after repeated nasals administrations of Oxytocin in PWS infants

Medical condition: Prader Willi Syndrom

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10010331 - Congenital, familial and genetic disorders	10036476	Prader-Willi syndrome	PT

Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18

Gender: Male, Female

Trial protocol: FR (Ongoing)

Trial results: (No results available)

EudraCT Number: 2017-000540-18

Sponsor Protocol Number: VX16-661-114

Start Date:

Sponsor Name: Vertex Pharmaceuticals Incorporated

Full Title: Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population ...

Medical condition: Cystic Fibrosis

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10010331 - Congenital, familial and genetic disorders	10011762	Cystic fibrosis	PT

Population Age: Adolescents, Under 18, Adults

Gender: Male, Female

Trial protocol: FR (Completed) DE (Completed)

Trial results: View results

EudraCT Number: 2021-004057-23

Sponsor Protocol Number: 2021-12945

Start Date:

Sponsor Name: Radboudumc

Full Title: Ethanol submandibular duct ligation for drooling in children with neurodisabilities

Medical condition: Drooling or sialorrhea

Disease:

Version

SOC Term

Classification Code

Term

Level

Population Age: Adolescents, Under 18

Gender: Male, Female

Trial protocol: NL (Ongoing)

Trial results: (No results available)

EudraCT Number: 2018-002981-37

Sponsor Protocol Number: YKP3089C033

Start Date:

Sponsor Name: SK Life Science, Inc.

Full Title: A Multicenter Open-label Extension Study to Evaluate the Long-term Safety of Cenobamate Adjunctive Therapy in Subjects with Primary Generalized Tonic-Clonic Seizures

Medical condition: Primary Generalized Tonic-Clonic Seizures

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	100000004852	10018101	Generalised tonic-clonic seizures	HLT

Population Age: Adolescents, Under 18, Adults, Elderly

Gender: Male, Female

Trial protocol: SK (Ongoing) PL (Ongoing) CZ (Completed) BG (Completed)

Trial results: (No results available)

EudraCT Number: 2021-000891-12

Sponsor Protocol Number: 212149

Start Date:

Sponsor Name: GlaxoSmithKline Biologicals

Full Title: A staged Phase I/II observer-blind, randomised, controlled, multi-country study to evaluate the safety, reactogenicity, and immune responses to the GVGH altSonflex1-2-3 vaccine against S. sonnei an...

Medical condition: Prophylaxis for Shigellosis induced by Shigella sonnei, Shigella flexneri 1b, Shigella flexneri 2a and Shigella flexneri 3a.

Disease:	Version	SOC Term	Classification Code	Term	Level
	20.0	10021881 - Infections and infestations	10040550	Shigella infections	HLT
	20.0	10021881 - Infections and infestations	10054178	Shigella infection	PT
	20.0	10021881 - Infections and infestations	10040542	Shigella	LLT
	20.0	10021881 - Infections and infestations	10040547	Shigella flexneri	LLT
20.0	10021881 - Infections and infestations	10040551	Shigella sonnei	LLT
20.1	10021881 - Infections and infestations	10004016	Bacterial diarrhoea	PT
20.0	10017947 - Gastrointestinal disorders	10012735	Diarrhoea	PT

Population Age: Infants and toddlers, Children, Under 18, Adults

Gender: Male, Female

Trial protocol: BE (Ongoing)

Trial results: (No results available)

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