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NCT ID: NCT01309113 Completed - Clinical trials for Premenstrual Syndrome

Dose-dependent Effects of VAC BNO 1095 on Cyclic Mastodynia and Premenstrual Syndrome

Start date: March 2011
Phase: Phase 3
Study type: Interventional

Prospective, double-blind, placebo-controlled, 3 parallel groups, multi-center study in 180 patients with cyclic mastodynia with premenstrual syndrome. 225 patients will be screened to achieve 180 patients eligible for randomisation, 60 to each treatment group, of which 150 are expected to complete the study per protocol. Study objectives: Identification of the optimal dosage of VAC BNO 1095 (product name) film coated tablets for treatment of cyclic mastodynia and premenstrual syndrome. To prove the efficacy of VAC BNO 1095 film coated tablets in the treatment of cyclic mastodynia. Dose regimen: Group 1: VAC BNO 1095 1x10 mg: 1 tablet of verum in the morning, 1 placebo tablet in the evening Group 2: VAC BNO 1095 2x10 mg: 1 tablet of verum in the morning, 1 tablet of verum in the evening Group 3: Placebo: 1 tablet placebo in the morning, 1 tablet placebo in the evening The study consists of a 2-cycle run-in period, followed by 3 cycles of treatment. After first screening further visits are scheduled after the end of each of the first and second run-in cycle, and after the first, second and third treatment cycle, respectively. Visits will be performed during the menses at day 3 (-1+3 days), i.e. 2 days after day 1 of menstruation number n, with exception of the first screening visit which can be performed at any time prior to the first run-in cycle. Subsequently the time between the first study visit and the onset of the first run-in cycle menses T shall be added to the overall study duration. In case that the next menstruation does not commence as expected, the patient should contact her investigator immediately in order to schedule a new appointment, approximately on the actual day 3 of the menses.

NCT ID: NCT01306214 Completed - Obesity Clinical Trials

Safety and Efficacy of BI 10773 as add-on to Insulin Regimen in Patients With Type 2 Diabetes Mellitus

Start date: February 2011
Phase: Phase 3
Study type: Interventional

This trial will evaluate use of BI 10773 as add-on to insulin regimen alone or with metformin in patients with typr 2 diabetes. Both lowering glucose and HbA1c and reducing the use of insulin in this population would provide significant new information for the BI 10773 use and would offer a potential new therapeutic option in this population.

NCT ID: NCT01303315 Terminated - Clinical trials for Diabetes Mellitus, Type 2

TANTALUS Therapy in Type 2 Diabetic Patients Intolerant or Inadequately Responsive to GLP-1 Receptor Agonist Therapy

Start date: January 2011
Phase: N/A
Study type: Interventional

To assess the TANTALUS therapy in type 2 diabetic patients who can not tolerate GLP-1 agonist due to unacceptable side effects; and to assess the TANTALUS therapy in type 2 diabetic patients who do not sufficiently benefit from GLP-1 receptor agonist therapy

NCT ID: NCT01303224 Completed - Clinical trials for Irritable Bowel Syndrome With Diarrhea

Ibodutant for Relief of Irritable Bowel Syndrome With Diarrhoea (IBS-D)

IRIS-2
Start date: October 2010
Phase: Phase 2
Study type: Interventional

Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. This trial aims at the evaluation of the efficacy and safety of the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.

NCT ID: NCT01302067 Completed - Overactive Bladder Clinical Trials

A 12 Week Study to Confirm the Effectiveness of 8mg of Fesoterodine Compared to 4mg of Fesoterodine

Start date: May 2011
Phase: Phase 4
Study type: Interventional

This study is designed to confirm if 8mg of fesoterodine is more effective in reducing overactive bladder symptoms than 4mg of fesoterodine. In addition the study is designed to assess if the higher dose reduces the overall effect of overactive bladder on the subject's daily life more than the lower dose. The study also assesses the side effects and safety of the two doses.

NCT ID: NCT01300819 Completed - Clinical trials for Idiopathic Parkinson's Disease

Placebo-controlled Study in Patients With Parkinson's Disease to Evaluate the Effect of Rotigotine on Non-motor Symptoms

Start date: February 2011
Phase: Phase 4
Study type: Interventional

The primary objective of this study was to demonstrate that Rotigotine improves non-motor symptoms compared to Placebo in subjects with Parkinson's Disease.

NCT ID: NCT01296620 Completed - Clinical trials for Gastrointestinal Dysmotility

Ulimorelin Study of Efficacy and Safety (ULISES 008)

Start date: February 2011
Phase: Phase 3
Study type: Interventional

Post-operative administration of ulimorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial large bowel resection

NCT ID: NCT01295372 Completed - Schizophrenia Clinical Trials

Safety and Efficacy of Zicronapine in Patients With Schizophrenia

Start date: April 2011
Phase: Phase 3
Study type: Interventional

To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment.

NCT ID: NCT01292109 Completed - Bowel Cleanliness Clinical Trials

A Study of PICOPREP in Patients Needed to Clean the Bowel Prior to X-ray Examination, Endoscopy or Surgery.

Start date: December 2010
Phase: N/A
Study type: Observational

The study serves as a confirmation of safety, tolerance and efficacy of PICOPREP in clinical practice.

NCT ID: NCT01291810 Completed - Crohn's Disease Clinical Trials

Clinical Efficacy of TNFa Kinoid in Crohn's Disease Patients

Start date: February 2011
Phase: Phase 2
Study type: Interventional

The safety and immunogenicity of the TNFα-Kinoid (TNF-K) have been evaluated in a phase I-II clinical study conducted in subjects with Crohn's Disease (CD). Preliminary results of clinical efficacy are promising. The principal aim of the present study is to confirm the clinical efficacy of the TNF-K in subjects with moderate to severe CD. Subjects with secondary resistance or intolerance to anti-TNFα monoclonal antibodies will be enrolled in this trial. In addition, the immune responses and the safety elicited by TNF-K will also be evaluated.