scholarly journals Erratum: A Randomized, Double‐Blind, Placebo‐Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss

Obesity ◽  
2019 ◽  
Keyword(s):  
Weight Loss ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo

A phase 3, multicenter, double-blind, placebo-controlled trial of lenvatinib (E7080) in patients with 131I-refractory differentiated thyroid cancer (SELECT).

2014 ◽  
Vol 32 (18_suppl) ◽  
pp. LBA6008-LBA6008 ◽  
Author(s):  
Martin Schlumberger ◽  
Makoto Tahara ◽  
Lori J. Wirth ◽  
Bruce Robinson ◽  
Marcia S. Brose ◽  
...  
Keyword(s):  
Weight Loss ◽  
Thyroid Cancer ◽  
Adverse Events ◽  
Differentiated Thyroid Cancer ◽  
Kinase Inhibitor ◽  
Controlled Trial ◽  
Controlled Study ◽  
Phase 3 ◽  
Double Blind ◽  
Double Blind Placebo

LBA6008 Background: Lenvatinib (LEN) is an oral tyrosine kinase inhibitor of the VEGFR1-3, FGFR1-4, PDGFRβ, RET, and KIT signaling networks. Based on efficacy results of the phase 2 study of patients (pts) with 131I-refractory differentiated thyroid cancer (RR-DTC), this phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT) was developed. Methods: This randomized, double-blind, placebo (PBO)-controlled study enrolled pts with RR-DTC with documented disease progression within 13 months (mo). Pts were stratified by age (≤65, >65 years), region and ≤1 prior VEGFR-targeted therapies and randomized 2:1 to LEN or PBO (24mg/d, 28-d cycle). Upon progression, pts receiving PBO could crossover to open-label LEN. The primary endpoint was PFS assessed by Independent Radiologic Review; secondary endpoints included overall response rate (ORR; complete response [CR] + PR), overall survival (OS) and safety. Results: 392 pts (63.0 years median age; 51.0% male) were randomized. Pts on LEN had a significantly prolonged PFS vs PBO (hazard ratio 0.21, 95% confidence interval [CI] 0.14–0.31; P <.0001); median PFS was LEN: 18.3 mo (95% CI 15.1–not evaluable), PBO: 3.6 mo (95% CI 2.2–3.7). A LEN PFS benefit was observed in all predefined subgroups; median LEN PFS for pts with prior vs no prior VEGF-therapy was 15.1 mo (n=66) and 18.7 mo (n=195), respectively. Rates (n) of CRs were LEN: 1.5% (4), PBO: 0; PRs were LEN: 63.2% (165), PBO: 1.5% (2).Median exposure duration was LEN: 13.8 mo, PBO: 3.9 mo; median time to LEN response was 2.0 mo. Median OS has not been reached; deaths per arm were LEN: 71 (27.2%), PBO: 47 (35.9%). The 5 most common LEN treatment-related adverse events (TRAEs; any grade) were hypertension (68%), diarrhea (59%), appetite decreased (50%), weight loss (46%), nausea (41%). LEN grade ≥3 TRAEs (≥5%) were hypertension (42%), proteinuria (10%), weight loss (10%), diarrhea (8%), appetite decreased (5%). The dose was reduced in 78.5% of pts and discontinued due to adverse events (AEs) in 14.2% of pts. Conclusions: LEN significantly improved PFS compared with PBO in pts with progressive RR-DTC. There were no unexpected toxicities and AEs were manageable. Clinical trial information: NCT01321554.

A Multicentre Study Comparing Mazindol and Placebo in Obese Patients

1977 ◽  
Vol 5 (2) ◽  
pp. 85-90 ◽  
Author(s):  
Barry R Walker ◽  
Ian M Ballard ◽  
Jerome A Gold
Keyword(s):  
Weight Loss ◽  
Therapy Group ◽  
Initial Therapy ◽  
Drop Out ◽  
Controlled Study ◽  
Obese Patients ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Behavioural Modification ◽  
Drop Out Rate

Mazindol is chemically unrelated to the phenethylamines and has not shown the side-effects or abuse potential of the amphetamine anorectics. To further define its potential for causing weight loss, a six-week double-blind placebo controlled study was undertaken in four centres. A common protocol was used except that in one centre, behavioural modification also was employed, whereas in the other centres, no additional measures were used to cause weight loss. Two hundred and forty-five obese patients were assigned randomly to two mazindol groups and one placebo group in each centre. Ninety-eight and forty patients receiving mazindol and placebo respectively completed the protocol. The conclusions were: (a) no significant clinical or laboratory abnormalities occurred from mazindol therapy, (b) the placebo therapy patients did not lose weight without behavioural modification, (c) the placebo therapy group had a higher drop-out rate compared to the mazindol therapy group attributable to the patients' dissatisfaction with failure to lose weight, (d) mazindol therapy without behavioural modification and behavioural modification alone both resulted in a statistically significant mean weight loss of 1 pound/patient/week and (e) mazindol plus behavioural modification resulted in a greater mean weight loss of 1/2 pound/patient/week than with behavioural modification alone. Hence, mazindol is of value in the initial therapy of obesity.

A Randomized, Double-Blind, Placebo-Controlled Study of a Blend of Herbal Extracts Taken Once Per Day for Weight Loss in Healthy Volunteers

2019 ◽  
pp. 1-8
Author(s):  
Eli Kassis
Keyword(s):  
Weight Loss ◽  
Body Weight ◽  
Waist Circumference ◽  
Health And Safety ◽  
Controlled Study ◽  
Herbal Extracts ◽  
Double Blind ◽  
Release Formulation ◽  
Double Blind Placebo ◽  
Preclinical And Clinical Studies

Aims: We previously demonstrated that a blend of herbal extracts (Weighlevel®; a mixture of extracts from the leaves of Alchemilla vulgaris, Olea europaea, Mentha longifolia and from the seeds of Cuminum cyminum) taken 3 times per day produces weight loss in preclinical and clinical studies. The aim of the present study was to test the efficacy of a new slow-release formulation (Weighlevel® One) taken once per day on change in body weight and related measures. Study Design:  Randomized, double-blind, placebo-controlled study. Place and Duration of Study: Health Clinics in Copenhagen, Denmark between 7 January 2016 and 5 March 2016. Methodology: Thirty-six adult subjects were randomized to consume the herbal blend (n = 20) or placebo (n = 16) once per day for 8 weeks. Weight and waist circumference were assessed weekly. The primary endpoint was the change from baseline in body weight for the herbal blend group compared with placebo. Secondary assessments included waist circumference, appetite, craving, bowel health, and safety and tolerability. Results: After 8 weeks, the herbal blend group lost an average of 3.7 kg (95% CI of 3.0 to 4.5 kg); whereas the placebo group lost 0.1 kg (95% CI of -0.7 to 1.0 kg). This difference in mean weight loss between the herbal blend and placebo groups was statistically significant (P <.001). A statistically significant reduction in waist circumference was also observed for the herbal blend compared with placebo (P <.001). The herbal blend was well tolerated; no adverse events were reported. Conclusion: Daily administration of this blend of herbal extracts, administered once daily, may produce weight loss.

scholarly journals A Randomized, Double‐Blind, Placebo‐Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss

Obesity ◽  
2018 ◽  
Vol 27 (2) ◽  
pp. 205-216 ◽  
Author(s):  
Frank L. Greenway ◽  
Louis J. Aronne ◽  
Anne Raben ◽  
Arne Astrup ◽  
Caroline M. Apovian ◽  
...  
Keyword(s):  
Weight Loss ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo
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