scholarly journals The Probiotic Strain H. alvei HA4597® Improves Weight Loss in Overweight Subjects under Moderate Hypocaloric Diet: A Proof-of-Concept, Multicenter Randomized, Double-Blind Placebo-Controlled Study

Nutrients ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1902
Author(s):  
Pierre Déchelotte ◽  
Jonathan Breton ◽  
Clémentine Trotin-Picolo ◽  
Barbara Grube ◽  
Constantin Erlenbeck ◽  
...  
Keyword(s):  
Weight Loss ◽  
Primary Endpoint ◽  
Randomized Study ◽  
Probiotic Strain ◽  
Hypocaloric Diet ◽  
Controlled Study ◽  
Hip Circumference ◽  
Double Blind ◽  
Fasting Glycemia ◽  
Overweight Subjects

Background: Increasing evidence supports the role of the gut microbiota in the control of body weight and feeding behavior. Moreover, recent studies have reported that the probiotic strain Hafnia alvei HA4597® (HA), which produces the satietogenic peptide ClpB mimicking the effect of alpha-MSH, reduced weight gain and adiposity in rodent models of obesity. Methods: To investigate the clinical efficacy of HA, 236 overweight subjects were included, after written informed consent, in a 12-week prospective, double-blind, randomized study. All subjects received standardized counselling for a −20% hypocaloric diet and were asked to maintain their usual physical activity. Subjects of the HA group received two capsules per day providing 100 billion bacteria per day and subjects in the Placebo (P) group received two placebo capsules. The primary endpoint was the percentage of subjects achieving a weight loss of at least 3% after 12 weeks. Intention-to-treat statistical analysis was performed using exact-Fischer, Mann-Whitney and paired-Wilcoxon tests as appropriate. Results: In the HA group, significantly more subjects (+33%) met the primary endpoint than in the P group (54.9 vs. 41.4%, p = 0.048). In the HA group, an increased feeling of fullness (p = 0.009) and a greater loss of hip circumference (p < 0.001) at 12 weeks were also observed. Fasting glycemia at 12 weeks was significantly lower (p < 0.05) in the HA compared to P group. Clinical and biological tolerance was good in both groups. Conclusions: A 12-week treatment with the probiotic strain H. alvei HA4597® significantly improves weight loss, feeling of fullness and reduction of hip circumference in overweight subjects following moderate hypocaloric diet. These data support the use of H. alvei HA4597® in the global management of excess weight.

A phase III randomized study of apremilast, an oral phosphodiesterase 4 inhibitor, for active ankylosing spondylitis

2021 ◽  
pp. jrheum.201088
Author(s):  
Peter C. Taylor ◽  
Désirée van der Heijde ◽  
Robert Landewé ◽  
Shannon McCue ◽  
Sue Cheng ◽  
...  
Keyword(s):  
Ankylosing Spondylitis ◽  
Primary Endpoint ◽  
Randomized Study ◽  
Phase Iii ◽  
Controlled Study ◽  
Double Blind ◽  
Upper Respiratory Infection ◽  
Phosphodiesterase 4 ◽  
The Impact ◽  
Phosphodiesterase 4 Inhibitor

Objective To evaluate the efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with active ankylosing spondylitis (AS). Methods This phase III, multicenter, double-blind, placebo-controlled study (NCT01583374) randomized patients with active AS (1:1:1) to placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily for 24 weeks, followed by a long-term extension phase (up to 5 years). The primary endpoint was assessment of the SpondyloArthritis International Society 20 (ASAS 20) response at Week 16. The impact of treatment on radiographic outcomes after 104 weeks was assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). Results In total, 490 patients with active AS were randomized in the study (placebo: n=164; apremilast 20 mg twice daily: n=163; apremilast 30 mg twice daily: n=163). The primary endpoint of ASAS 20 response at Week 16 was not met (placebo: 37%; apremilast 20 mg twice daily: 35%; apremilast 30 mg twice daily: 33%; p=0.44 vs placebo). At Week 104, mean (SD) changes from baseline in mSASSS were 0.83 (3.6), 0.98 (2.2), and 0.57 (1.9) in patients initially randomized to placebo, apremilast 20 mg twice daily, and apremilast 30 mg twice daily, respectively. The most frequently reported adverse events through Week 104 were diarrhea, nasopharyngitis, upper respiratory infection, and nausea. Conclusion No clinical benefit was observed with apremilast treatment in patients with active AS. The safety and tolerability of apremilast were consistent with its known profile.

Plerixafor and G-CSF versus placebo and G-CSF to mobilize hematopoietic stem cells for autologous stem cell transplantation in patients with multiple myeloma

Blood ◽  
2009 ◽  
Vol 113 (23) ◽  
pp. 5720-5726 ◽  
Author(s):  
John F. DiPersio ◽  
Edward A. Stadtmauer ◽  
Auayporn Nademanee ◽  
Ivana N. M. Micallef ◽  
Patrick J. Stiff ◽  
...  
Keyword(s):  
Stem Cells ◽  
Multiple Myeloma ◽  
Hematopoietic Stem Cells ◽  
Primary Endpoint ◽  
Controlled Study ◽  
Double Blind ◽  
Hematopoietic Stem ◽  
Injection Site Reactions ◽  
Cd34 Cells ◽  
Stimulating Factor

Abstract This phase 3, multicenter, randomized (1:1), double-blind, placebo-controlled study evaluated the safety and efficacy of plerixafor with granulocyte colony-stimulating factor (G-CSF) in mobilizing hematopoietic stem cells in patients with multiple myeloma. Patients received G-CSF (10 μg/kg) subcutaneously daily for up to 8 days. Beginning on day 4 and continuing daily for up to 4 days, patients received either plerixafor (240 μg/kg) or placebo subcutaneously. Starting on day 5, patients began daily apheresis for up to 4 days or until more than or equal to 6 × 106 CD34+ cells/kg were collected. The primary endpoint was the percentage of patients who collected more than or equal to 6 × 106 CD34+ cells/kg in less than or equal to 2 aphereses. A total of 106 of 148 (71.6%) patients in the plerixafor group and 53 of 154 (34.4%) patients in the placebo group met the primary endpoint (P < .001). A total of 54% of plerixafor-treated patients reached target after one apheresis, whereas 56% of the placebo-treated patients required 4 aphereses to reach target. The most common adverse events related to plerixafor were gastrointestinal disorders and injection site reactions. Plerixafor and G-CSF were well tolerated, and significantly more patients collected the optimal CD34+ cell/kg target for transplantation earlier compared with G-CSF alone. This study is registered at www.clinicaltrials.gov as #NCT00103662.

Efficacy of Phenazone in the Treatment of Acute Migraine Attacks: A Double-Blind, Placebo-Controlled, Randomized Study

Cephalalgia ◽  
2004 ◽  
Vol 24 (10) ◽  
pp. 888-893 ◽  
Author(s):  
H Göbel ◽  
A Heinze ◽  
U Niederberger ◽  
T Witt ◽  
V Zumbroich
Keyword(s):  
Adverse Events ◽  
Randomized Study ◽  
Controlled Study ◽  
Acute Migraine ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Number Of Patients ◽  
Significant Difference ◽  
Main Target

In this study we compared the efficacy of 1000 mg phenazone with that of placebo in the treatment of acute migraine attacks in a randomized double-blind, placebo-controlled study of 208 patients. The main target criterion was the number of patients with a pain reduction from severe or moderate to slight or no pain 2 h after taking the pain medication. The percentage of patients satisfying the main target criterion was 48.6% for phenazone and 27.2% ( P < 0.05) for placebo. Freedom from pain after 2 h was reported by 27.6% with phenazone treatment and 13.6% ( P < 0.05) with placebo. Compared with placebo, the phenazone treatment also resulted in a significant improvement in the associated migraine symptoms of nausea, phonophobia and photophobia. Of patients treated with phenazone 11.4%, and 5.8% of those treated with placebo reported adverse events. There was no significant difference between the groups with regard to numbers of patients with adverse events. No serious adverse events occurred. The results show that phenazone at a dosage of 1000 mg is effective and well tolerated in the treatment of acute migraine attacks.

scholarly journals Efficacy of dexamethasone in reducing the incidence of postoperative sore throat: a double blind randomized study

2018 ◽  
Vol 5 (1) ◽  
pp. 10-15 ◽  
Author(s):  
Sujita Manandhar ◽  
Kishor Manandhar ◽  
Sharad Khakrel
Keyword(s):  
Endotracheal Tube ◽  
Sore Throat ◽  
Randomized Study ◽  
Saline Group ◽  
Controlled Study ◽  
Control Group ◽  
Lower Grade ◽  
Postoperative Sore Throat ◽  
Double Blind ◽  
Dexamethasone Group

Introductions: Postoperative sore throat (POST) is a commonly seen adverse event after general anesthesia with endotracheal intubation. Dexamethasone, a potent corticosteroid with anti-inflammatory action is the most popular steroid studied in this regard with positive results. Methods: This randomized, prospective, double-blinded, placebo-controlled study was conducted on one hundred and ten adult patients of either sex, American Society of Anesthesiologists physical status I & II, undergoing elective surgeries requiring endotracheal tube intubation. After obtaining written informed consent, they were randomly divided into Control (A, n=55) and Dexamethasone (B, n=55) groups and received either an injection of Dexamethasone (Group B) 8 mg intravenously or an equivalent volume of Normal Saline (Group A) just before entering the operating theatre. All the patients received a similar anesthesia with endotracheal tube intubation and at the end of surgery, extubated and transferred to the post-anesthesia care unit. The incidence and severity of sore throat were assessed at 1, 6 and 24 hours post-extubation. Severity of sore throat were graded on a 4 point scale, p <0.05 was considered significant. Results: Incidence of POST in Dexamethasone group was found significantly low compared to the control group up to six hours (p<0.05) but was comparable at 24 hours post extubation. Severity of POST in the study group was of lower grade in compare to control group. Conclusions: Prophylactic intravenous Dexamethasone 8 mg administered to patients undergoing elective surgeries requiring endotracheal tube intubation significantly reduces the incidence and severity of POST up to six hours post-extubation.

Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin alfa Every 3 Weeks for the Treatment of Chemotherapy-Induced Anemia.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 3556-3556 ◽  
Author(s):  
Kerry Taylor ◽  
Peter Ganly ◽  
Veena Charu ◽  
Joseph DiBenedetto ◽  
Karolyn Kracht ◽  
...  
Keyword(s):  
Placebo Group ◽  
Primary Endpoint ◽  
Darbepoetin Alfa ◽  
Dose Adjustment ◽  
Nonsmall Cell Lung Cancer ◽  
Target Range ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Hb Concentration

Abstract Background: Darbepoetin alfa (Aranesp®; DA) has been shown to be safe and effective for treating chemotherapy-induced anemia (CIA). The ability to administer darbepoetin alfa every 3 weeks (Q3W) (coincident with chemotherapy) would simplify the treatment of CIA. We report results from the first multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial evaluating efficacy and safety of fixed Q3W administration of an erythropoietic agent. Methods: This study enrolled subjects ≥18 years, diagnosed with anemia (hemoglobin [Hb]&lt;11g/dL) and a nonmyeloid malignancy with ≥12 weeks of planned chemotherapy. Patients (N=391) were randomized 1:1 to receive DA 300 μg or placebo Q3W for 15 weeks. Dose adjustment rules included: increase (to 500 μg Q3W) if Hb concentration was &lt;9 g/dL at week 4 or &lt;10 g/dL (and had &lt;1-g/dL increase) at week 7, or decrease (dependent on previous dose) if Hb concentration was ≥13 g/dL or had ≥1-g/dL increase in any 2-week period. Efficacy was assessed by incidence of red blood cell (RBC) transfusions and achievement of target Hb of ≥11 g/dL (not exceeding 13 g/dL), consistent with ASH/ASCO, NCCN, EORTC evidence-based practice guidelines. Results: A total of 386 randomized patients were included in the analysis. Demographic characteristics were similar between the 2 groups. Mean (SD) Hb levels at baseline were 10.03 (0.86) and 10.05 (0.92) g/dL in the placebo and DA groups, respectively. The most common tumor types were breast (23%), colon (11%), nonsmall-cell-lung cancer (10%), and hematologic malignancies (11%; 8% Non-Hodgkin’s Lymphoma). The incidence of RBC transfusions from week 5 to the end of treatment phase (EOTP) (the primary endpoint) was significantly lower for the DA group than for the placebo group (P&lt;0.001) (see Table). Hb levels rose steadily in the DA group through approximately week 9, increasing by a mean (SD) of 1.08 (1.28) g/dL from baseline, and then remained relatively stable (see Figure). The proportion of patients achieving Hb target range from week 5 to EOTP was significantly higher for the DA group than for the placebo group (P&lt;0.001). Dose adjustment rules helped to maintain Hb levels within target range. The safety profile of DA was consistent with that observed in previous studies. Rapid increases in Hb concentration or increases to ≥13 g/dL were not associated with adverse events. Conclusions: Fixed Q3W administration of DA is well tolerated and effective for the treatment of CIA. Summary of Results Placebo Darbepoetin alfa KM = Kaplan-Meier estimate Week 5 to EOTP N=185 N=181 Transfusions, KM (95% CL) (primary endpoint) 41% (34, 49) 24% (18, 30) Achievement of target Hb, KM (95% CL) 48% (41, 56) 82% (76, 88) Week 1 to EOTP N=193 N=193 Transfusions, KM (95% CL) 47% (40, 54) 30% (23, 36) Median time to target Hb, weeks (95% CL) 12 (9, 16) 6 (3, 7) Figure Figure

Concordance between independently and investigator-assessed progression-free survival in CLEOPATRA.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e11055-e11055
Author(s):  
David Miles ◽  
Sandra M. Swain ◽  
Young-Hyuck Im ◽  
Adam Knott ◽  
Graham Ross ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Progression Free Survival ◽  
Sensitivity Analyses ◽  
Controlled Study ◽  
Equal Proportion ◽  
Her2 Positive ◽  
Double Blind ◽  
Free Survival ◽  
Independent Review ◽  
Event Based

e11055^ Background: In CLEOPATRA, pertuzumab (P) + trastuzumab (T) + docetaxel (D) was compared to placebo (Pla)+T+D in HER2-positive 1st-line MBC. In MBC trials, PFS rather than overall survival is often defined as the primary endpoint as PFS data are available earlier and later-line therapy does not impact results. The primary endpoint in CLEOPATRA, PFS, was assessed by an Independent Review Facility (IRF), with investigator (inv)-assessed PFS as a secondary endpoint. As a measure of consistency and robustness, concordance between IRF- and inv-assessed PFS was analyzed. Methods: PFS was defined as time from randomization to first documented radiographic evidence of progressive disease (PD) or death from any cause within 18 wk of the last IRF tumor assessment. Tumor assessments took place every 9 wk and continued until IRF-confirmed PD. Treatment decisions were solely based on the inv’s assessment of PD. Indicators of concordance between IRF- and inv-assessed PFS included: PFS event by IRF only; PFS event by inv only; PFS event by IRF and inv; no PFS event by IRF and inv. These indicators were assessed at any time on study, within 30 d or within 9 wk. Several pre-specified sensitivity analyses for PFS were also performed. Results: 808 pt were enrolled and central tumor assessments performed for 781 pt. Compliance with the schedule of tumor assessments was generally high and comparable between arms, with >78% of pt undergoing assessments within 7 d of the scheduled visit over the 1st yr. At any time on study, concordance between IRF- and inv-assessed PFS was 85%. Of the 15% discordant cases, an equal proportion was assessed by the IRF as a PFS event but not by the inv and vice versa. Estimates of the median time to PFS event based on IRF and inv assessments were identical, Pla+T+D: 12.4 mo, P+T+D: 18.5 mo (IRF: HR 0.62, P < .0001; inv: HR 0.65, P < .0001). Conclusions: Concordance between IRF- and inv-assessed PFS was high, supporting consistency and robustness of the PFS analyses. The subjective nature of PD and potential for bias were reduced by the double-blind, placebo-controlled study design; RECIST 1.0 criteria; identical schedule of assessments in both arms; IRF review and continuation of tumor assessments until IRF confirmation of PD.

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