Open label study of 1% retinol and double-blind placebo-controlled study of 0.5% retinol both in an oil-free aqueous protein rich suspension

2013 ◽  
Vol 68 (4) ◽  
pp. AB25
Keyword(s):  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Double Blind Placebo ◽  
Protein Rich

scholarly journals A179 CANADIAN INVOLVEMENT IN THE EVALUATION OF NOVEL THERAPY FOR DIABETIC GASTROPARESIS: OVERVIEW OF PLEDGE TRIALS

2020 ◽  
Vol 3 (Supplement_1) ◽  
pp. 45-47
Author(s):  
L W Liu ◽  
M Syrzycka ◽  
P Janiszewski ◽  
L Kemps ◽  
B Degeronimo
Keyword(s):  
Diabetic Gastroparesis ◽  
Extension Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Safety And Efficacy ◽  
Double Blind Placebo ◽  
The Third ◽  
Parallel Group

Abstract Background Diabetic gastroparesis(DG) is a serious, chronic complication of type 1 or 2 diabetes mellitus(DM) presenting with a delay in gastric emptying(GE). An estimated 3 million Canadians have been diagnosed with DM; up to 5% of these patients may develop DG. DG can result in poor glycemic control, recurrent nausea and vomiting, often resulting in hospitalization. To date, no effective treatments are available. A phase 2 study showed that relamorelin (RLM), a synthetic ghrelin agonist, was safe and effective in treating DG. Investigators across Canada are participating in a set of phase 3 international trials of RLM in the treatment of DG. Aims To report the Canadian involvement in the international effort to evaluate the safety and efficacy of RLM in the treatment of DG. PLEDGE is a set of 5 trials: two identical 12-week studies, a 46-week extension study, a 52-week exposure study, and an open-label extension study. Collectively, the data from these studies will help to evaluate the safety and efficacy of RLM, a novel treatment for Canadian patients living with DG. Methods Four global, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies compare the efficacy of RLM with placebo in participants with DG using composite endpoints of nausea, abdominal pain, postprandial fullness, bloating. Participants are randomized to RLM 10μg or placebo subcutaneously (SC) twice daily groups. The open-label continuation of treatment will follow participants until RLM becomes commercially available to provide long-term safety information to support the safe use of RLM as a chronic treatment of DG. As seen in Figure 1, participants from the two 12-week studies will rollover into the third study that will continue for 46 weeks. The fourth study will enroll participants that were not randomized in the first two studies because their symptoms were less severe and will also accept new participants. Participants will be randomized 2:1 to RLM 10μg or placebo SC twice daily groups. Participants from the third and fourth studies have the option to enroll in the open-label study. Results Target enrollment is approx. 1800 participants for the 4 global, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies and 1000 participants for the open label study. 700 sites are expected to participate globally; 15 Canadian sites in 6 provinces are participating. Conclusions Canadian centers are actively involved in the PLEDGE trials to help determine the efficacy and safety of RLM, a potential new treatment for DG. This publication increases awareness of the Canadian gastroenterology community, providing an option to refer interested patients to PLEDGE study centers. PLEDGE Studies (NCT03285308, NCT03426345, NCT03420781, NCT03383146, NCT03786380): Placebo-controlled, randomized RLM-MD-01/02/03/04 and open-label study 3071-305-020 to study the safety and efficacy of relamorelin for the treatment of diabetic gastroparesis Funding Agencies None

The premonitory phase of migraine and migraine management

Cephalalgia ◽  
2012 ◽  
Vol 33 (13) ◽  
pp. 1117-1121 ◽  
Author(s):  
Werner J Becker
Keyword(s):  
Literature Review ◽  
Migraine Attack ◽  
Management Strategy ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Medication Treatment ◽  
Premonitory Symptoms

Objective: The objective was to determine, through a literature review, whether treatment during the premonitory phase of migraine is a potentially useful migraine management strategy. Methods: A general literature review was done with regard to the nature of migraine premonitory symptoms, their frequency, their reliability in predicting migraine attacks, and the effectiveness of medication treatment when given during the premonitory phase. Results: Many different symptoms have been reported as premonitory symptoms that occur before migraine attacks. Up to 87% of patients with migraine may experience premonitory symptoms, although some studies have provided estimates as low as 33%. In selected patients, premonitory symptoms may be relatively reliable predictors of a migraine attack to follow. Both naratriptan (open-label study) and domperidone (double-blind, randomized, placebo-controlled study) have been reported to be effective when given during the premonitory phase. Conclusions: More research is needed, but there is some evidence that medication treatment during the premonitory phase has the potential to be helpful in selected patients with migraine.

XP-828L in the Treatment of Mild to Moderate Psoriasis: Randomized, Double-Blind, Placebo-Controlled Study

2006 ◽  
Vol 10 (5) ◽  
pp. 241-248 ◽  
Author(s):  
Yves Poulin ◽  
Robert Bissonnette ◽  
Christina Juneau ◽  
Kim Cantin ◽  
Rejean Drouin ◽  
...  
Keyword(s):  
Severity Index ◽  
Controlled Study ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Double Blind Placebo ◽  
Sweet Whey ◽  
Severity Index Score ◽  
Group A ◽  
Group B

Background: XP-828L, a protein extract obtained from sweet whey, has demonstrated potential benefit for the treatment of mild to moderate psoriasis in an open-label study. Objective: To study in a randomized, double-blind, placebo-controlled study the safety and efficacy of XP-828L in the treatment of mild to moderate psoriasis. Design: XP-828L 5 g/d (group A, n = 42) or placebo (group B, n = 42) was given orally for 56 days followed by XP-828L 5 g/d in group A and by XP-828L 10 g/d in group B for an additional 56 days. Results: Patients receiving XP-828L 5 g/d for 56 days had an improved Physician's Global Assessment (PGA) score compared with patients under placebo ( p < .05). Considering the data of group A only, the PGA score improved from day 1 to day 56 ( p < .01); the Psoriasis Area and Severity Index score improved as well, but to a lesser extent ( p < .05). Conclusion: Oral administration of 5 g/d XP-828L compared with a placebo significantly improved the PGA score of patients with mild to moderate psoriasis.

scholarly journals Intake safety of Lactobacillus helveticus SBT2171 and its effects on nasal and ocular symptoms associated with mites and house dust: An open-label study and a randomized, double-blind, placebo-controlled, parallel group study

2019 ◽  
Vol 9 (1) ◽  
pp. 52 ◽  
Author(s):  
Maya Yamashita ◽  
Eiji Kobatake ◽  
Shun Obuchi ◽  
Masayuki Iwai ◽  
Kazuyuki Ichikawa ◽  
...  
Keyword(s):  
House Dust ◽  
Daily Intake ◽  
Lactobacillus Helveticus ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Double Blind Placebo ◽  
Ocular Symptoms ◽  
Parallel Group

Background: We previously reported that Lactobacillus helveticus SBT2171 (LH2171) inhibited the proliferation and secretion of lipopolysaccharide-stimulated inflammatory cytokines in primary immune cells. Furthermore, in vivo administration of LH2171 has been demonstrated to suppress the incidence and development of murine rheumatoid arthritis. In this study, we evaluated whether the intake of drinkable yogurt (DY) containing LH2171 alleviated nasal and ocular symptoms of allergy to mites and house dust allergens. The safety of LH2171 was also confirmed in an independent, open-label study in 20 healthy subjects who consumed an excessive amount of LH2171.Methods: In study 1, the effect of daily intake of DY containing LH2171 for 12 weeks on nasal and ocular symptoms was evaluated in healthy men and women who tested positive for house dust or mite-specific IgE in a randomized, double-blind, placebo-controlled, parallel group study. One hundred subjects were divided into two groups: subjects taking placebo DY (P group, n = 50) and subjects taking DY containing approximately 1 × 109 cells of LH2171 (LH2171 group, n = 50) daily for the 12 weeks. After excluding subjects that met exclusion criteria, data obtained from 94 subjects (LH2171 group: n = 48; P group: n = 46) were analyzed to establish LH2171 efficacy. LH2171 safety was assessed in an independent, open-label trial in 20 subjects (study 2) who consumed an excessive amount of DY containing approximately 3 × 109 LH2171 cells.Results: In study 1, the decreases in the total scores of the nasal and ocular discomfort between week 0 and week 8 in LH2171 group were significantly larger than those in P group.　 Additionally, the number of sneezes decreased significantly in LH2171 group compared with P group on weeks 9–12 compared to the number of sneezes at baseline. In study 2, no adverse effects of LH2171 on systolic bold pressure, diastolic blood pressure, pulse rate, body weight, blood and urinalysis parameters were reported.Clinical trial registration: UMIN000027791 (study 1), UMIN000029058 (study 2).Conclusion: Daily intake of LH2171 for 12 weeks may regulate immune function and improve nasal and ocular symptoms in the subjects with mite or house dust allergy.

scholarly journals Tasimelteon safely and effectively improves sleep in Smith–Magenis syndrome: a double-blind randomized trial followed by an open-label extension

2021 ◽  
Author(s):  
Christos M. Polymeropoulos ◽  
Justin Brooks ◽  
Emily L. Czeisler ◽  
Michaela A. Fisher ◽  
Mary M. Gibson ◽  
...  
Keyword(s):  
Sleep Quality ◽  
Crossover Study ◽  
Total Sleep Time ◽  
Sleep Time ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Sleep Complaints ◽  
Open Label Extension

Abstract Purpose To assess the efficacy of tasimelteon to improve sleep in Smith–Magenis syndrome (SMS). Methods A 9-week, double-blind, randomized, two-period crossover study was conducted at four US clinical centers. Genetically confirmed patients with SMS, aged 3 to 39, with sleep complaints participated in the study. Patients were assigned to treatment with tasimelteon or placebo in a 4-week crossover study with a 1-week washout between treatments. Eligible patients participated in an open-label study and were followed for >3 months. Results Improvement of sleep quality (DDSQ50) and total sleep time (DDTST50) on the worst 50% of nights were primary endpoints. Secondary measures included actigraphy and behavioral parameters. Over three years, 52 patients were screened, and 25 patients completed the randomized portion of the study. DDSQ50 significantly improved over placebo (0.4, p = 0.0139), and DDTST50 also improved (18.5 minutes, p = 0.0556). Average sleep quality (0.3, p = 0.0155) and actigraphy-based total sleep time (21.1 minutes, p = 0.0134) improved significantly, consistent with the primary outcomes. Patients treated for ≥90 days in the open-label study showed persistent efficacy. Adverse events were similar between placebo and tasimelteon. Conclusion Tasimelteon safely and effectively improved sleep in SMS.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years

2000 ◽  
Vol 6 (4) ◽  
pp. 255-266 ◽  
Author(s):  
K P Johnson ◽  
B R Brooks ◽  
C C Ford ◽  
A Goodman ◽  
J Guarnaccia ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Relapse Rate ◽  
Open Label ◽  
Double Blind ◽  
Open Label Study ◽  
Label Study ◽  
Open Label Phase ◽  
Multiple Sclerosis Patients ◽  
To Receive

In a randomized, placebo-controlled, double-blind study, glatiramer acetate (Copaxone®) reduced the relapse rate and slowed accumulation of disability for patients with relapsing-remitting multiple sclerosis. Of the original 251 patients randomized to receive glatiramer acetate or placebo, 208 chose to continue in an open-label study with all patients receiving active drug. The majority of the original double-blind cohort continues to receive glatiramer acetate by daily subcutaneous injection and are evaluated at 6-month intervals and during suspected relapse. The data reported here are from approximately 6 years of organized evaluation, including the double-blind phase of up to 35 months and the open-label phase of over 36 months. Daily subcutaneous injections of 20 mg glatiramer acetate were well tolerated. The mean annual relapse rate of the patients who received glatiramer acetate since randomization and continued into the open-label study was 0.42 (95% confidence interval (CI), CI=0.34-0.51). The rate per year has continued to drop and for the sixth year is 0.23. Of the group who have received glatiramer acetate without interruption for 5 or more years, 69.3% were neurologically unchanged or have improved from baseline by at least one step on the Expanded Disability Status Scale (EDSS). Patients who left the open-label phase were surveyed by questionnaire. The majority responded, providing information about their current status and reasons for dropping out. This study demonstrates the sustained efficacy of glatiramer acetate in reducing the relapse rate and in slowing the accumulation of disability in patients with relapsing forms of multiple sclerosis.

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