Changes in ocular signs and symptoms in patients switching from bimatoprost–timolol to tafluprost–timolol eye drops: an open-label phase IV study

ObjectivesBimatoprost–timolol (bimatoprost 0.03%–timolol 0.5% fixed-dose combination [FDC]) and tafluprost–timolol (tafluprost 0.0015%–timolol 0.5% FDC) eye drops are currently the only topical intraocular pressure (IOP)-reducing therapies available as preservative-free (PF) prostaglandin and timolol FDC. The aim of this study was to investigate changes to ocular signs and symptoms when patients with ocular hypertension (OH) or open-angle glaucoma (OAG) switched from PF or benzalkonium chloride (BAK)-preserved bimatoprost–timolol to PF tafluprost–timolol eye drops.DesignThis was a 12-week, open-label, phase IV study.SettingSixteen centres in Finland, Germany, Italy and the UK.ParticipantsPatients with OH or OAG (IOP on medication ≤21 mm Hg), treated with PF or BAK-preserved bimatoprost–timolol for ≥4 weeks before screening, and presenting with conjunctival hyperaemia and ≥1 ocular symptom.InterventionsPatients were switched to PF tafluprost–timolol once daily in the treated eye(s).Primary and secondary outcome measuresThe primary endpoints were change from screening to week 12 in conjunctival hyperaemia and worst ocular symptom. The secondary outcome measures were changes from screening in ocular signs (other than conjunctival hyperaemia) and symptoms at week 12.ResultsOf 123 enrolled patients, 121 were included in the intention-to-treat dataset, of which all were Caucasian and 54.5% were female; 76 patients used BAK-preserved bimatoprost–timolol and 45 used PF drops. Conjunctival hyperaemia and severity of worst ocular symptom following switch to PF tafluprost–timolol significantly reduced from screening to week 12 in all patients (p<0.001). The percentage of patients with ocular signs and symptoms was significantly reduced at week 12 compared with screening (p<0.001). IOP was not affected by the change of treatment.ConclusionsSwitching from BAK-preserved or PF bimatoprost–timolol to tafluprost–timolol reduced both signs and symptoms of ocular surface disease with no clinically relevant effect on IOP.Trial registration numberEudraCT2014-005273-37; Results.

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Managing pasireotide-associated hyperglycemia: a randomized, open-label, Phase IV study

Pituitary ◽

10.1007/s11102-021-01161-4 ◽

2021 ◽

Author(s):

Susan L. Samson ◽

Feng Gu ◽

Ulla Feldt-Rasmussen ◽

Shaoling Zhang ◽

Yerong Yu ◽

...

Keyword(s):

Cushing’S Disease ◽

Rescue Therapy ◽

Antidiabetic Drugs ◽

Cushing's Disease ◽

Oral Antidiabetic Drugs ◽

Open Label ◽

Oral Antidiabetic ◽

Open Label Phase ◽

Core Phase ◽

Phase Iv

Abstract Purpose Pasireotide is an effective treatment for acromegaly and Cushing’s disease, although treatment-emergent hyperglycemia can occur. The objective of this study was to assess incretin-based therapy versus insulin for managing pasireotide-associated hyperglycemia uncontrolled by metformin/other permitted oral antidiabetic drugs. Methods Multicenter, randomized, open-label, Phase IV study comprising a core phase (≤ 16-week pre-randomization period followed by 16-week randomized treatment period) and optional extension (ClinicalTrials.gov ID: NCT02060383). Adults with acromegaly (n = 190) or Cushing’s disease (n = 59) received long-acting (starting 40 mg IM/28 days) or subcutaneous pasireotide (starting 600 µg bid), respectively. Patients with increased fasting plasma glucose (≥ 126 mg/dL on three consecutive days) during the 16-week pre-randomization period despite metformin/other oral antidiabetic drugs were randomized 1:1 to open-label incretin-based therapy (sitagliptin followed by liraglutide) or insulin for another 16 weeks. The primary objective was to evaluate the difference in mean change in HbA1c from randomization to end of core phase between incretin-based therapy and insulin treatment arms. Results Eighty-one (32.5%) patients were randomized to incretin-based therapy (n = 38 received sitagliptin, n = 28 subsequently switched to liraglutide; n = 12 received insulin as rescue therapy) or insulin (n = 43). Adjusted mean change in HbA1c between treatment arms was – 0.28% (95% CI – 0.63, 0.08) in favor of incretin-based therapy. The most common AE other than hyperglycemia was diarrhea (incretin-based therapy, 28.9%; insulin, 30.2%). Forty-six (18.5%) patients were managed on metformin (n = 43)/other OAD (n = 3), 103 (41.4%) patients did not require any oral antidiabetic drugs and 19 patients (7.6%) were receiving insulin at baseline and were not randomized. Conclusion Many patients receiving pasireotide do not develop hyperglycemia requiring oral antidiabetic drugs. Metformin is an effective initial treatment, followed by incretin-based therapy if needed. ClinicalTrials.gov ID: NCT02060383.

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An open label single arm prospective clinical study on Vatagajankusharasa with Pippali Churna and Manjishta Kwatha as Anupana in Viswachi (cervical spondylosis)

Journal of Ayurveda and Integrated Medical Sciences (JAIMS) ◽

10.21760/jaims.5.1.13 ◽

2020 ◽

Vol 5 (01) ◽

pp. 73-80

Author(s):

Moh Gulfam ◽

Totad Muttappa ◽

Neelam Bisht ◽

Vishnu M L ◽

Yadu Gopan

Keyword(s):

Clinical Study ◽

Ordinal Data ◽

Cervical Spondylosis ◽

Signs And Symptoms ◽

Upper Extremities ◽

Secondary Outcome ◽

Prospective Clinical Study ◽

Rank Tests ◽

Open Label ◽

Signed Rank

Background: Viswachi is one among the 80 Nanatmaja Vata Vyadhi. This disease affects the neck and upper extremities with the signs and symptoms like Ruk, Stambha, Toda, Bahu Karmakshaya. Vatagajankusha Rasa is a combination of Vyosha, Bhasmas, Vatsanabha, Karkatasringi, Haritaki etc. It has Vatakaphahara, Vikasi, Vyavayi, Rasayana etc. properties. It is said to be effective in treating Visawachi in 7 days if given along with Pippali Churna and Manjishta Kwatha. Aims and Objectives: To evaluate the efficacy of Vatagajankusha Rasa with Pippali Churna and Manjishta Kwatha as Anupana in the management of Viswachi (Cervical spondylosis). Methodology: Among 35 registered patients, 30 completed the course of treatment. They were administered with Vatagajankusha Rasa 1 tablet (125 mg) after food with Anupana 3gm Pippali Churna and 15 ml Manjishta Kwatha twice daily (morning and evening) for a period of 7 days. Nominal and ordinal data were analysed using non parametric tests like McNemar and Wilcoxon’s signed rank tests respectively. Result: Assessment parameters like Ruk, Toda, Sthambha and Bahukarma Kshya. There was statistically significant improvement in the primary and secondary outcome measures (p less than 0.05 was observed). Conclusion: Vatagajankusha Rasa with Pippali Churna and Manjishta Kwatha as Anupana is effective in the management of Viswachi (Cervical spondylosis).

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OC 8489 CLINICAL DEVELOPMENT OF A THERAPEUTIC VACCINE FOR PREVENTION OF POST KALA AZAR DERMAL LEISHMANIASIS

BMJ Global Health ◽

10.1136/bmjgh-2019-edc.22 ◽

2019 ◽

Vol 4 (Suppl 3) ◽

pp. A9.2-A9

Author(s):

Paul Kaye ◽

Ahmed Musa ◽

Joseph Olobo ◽

Margaret Mbuchi ◽

Asrat Hailu Mekuria ◽

...

Keyword(s):

East Africa ◽

Therapeutic Vaccine ◽

Clinical Development ◽

Secondary Outcome ◽

Therapeutic Trial ◽

Secondary Outcome Measure ◽

Open Label ◽

Kala Azar ◽

Before And After ◽

Open Label Phase

BackgroundThe leishmaniases represent a complex of human diseases, with 350 million people at risk of infection worldwide. Although the potential benefits of vaccination have been well-recognised, no human vaccine is registered. Post-kala azar dermal leishmaniasis (PKDL) is a chronic skin disease often following treatment for visceral leishmaniasis (VL). In addition to affecting quality of life, evidence suggests that PKDL patients may also act as reservoirs for VL transmission. Hence, PKDL vaccines may have a significant impact on disease burden. We recently developed a third-generation adenoviral vaccine for leishmaniasis (ChAd63-KH) that has been evaluated for safety and immunogenicity in healthy volunteers (Osman et al,2017). ChAd63-KH is currently being evaluated for safety as a therapeutic in Sudanese PKDL patients, with a phase IIb RCT starting in late 2018. With EDCTP funding, we are initiating a new phase IIa/IIb study (PREV_PKDL) todetermine whether ChAd63-KH can prevent PKDL development.MethodsIn PREV_PKDL, we will conduct an open-label phase IIa safety study, followed by a placebo blinded, phase IIb RCT. Safety and clinical response represent primary outcome measures, and immunogenicity is a secondary outcome measure. In addition, working across the four countries of Leishmaniasis East Africa Platform (LEAP), we will use deep phenotyping methods to study the immune status of patients before and after treatment for VL to understand why PKDL development is limited to specific geographic regions. This work, and other research in the region, will be supported by the creation of a new flow cytometry ‘centre of excellence’ within LEAP.ResultsAn update on the progress of our current therapeutic trial in PKDL patients will be provided.ConclusionPREV_PKDL represents an important step in the clinical development of ChAd63-KH and will help develop capacity to support future vaccine and drug trials for leishmaniasis in the East Africa Region.

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Randomized, Open-Label, Phase IV, Korean Study of Kidney Transplant Patients Converting From Cyclosporine to Prolonged-Release Tacrolimus Plus Standard- or Reduced-Dose Corticosteroids

Transplantation Proceedings ◽

10.1016/j.transproceed.2019.01.057 ◽

2019 ◽

Vol 51 (3) ◽

pp. 749-760

Author(s):

C.H. Baek ◽

C.-D. Kim ◽

D.R. Lee ◽

Y.H. Kim ◽

J. Yang ◽

...

Keyword(s):

Kidney Transplant ◽

Prolonged Release ◽

Open Label ◽

Reduced Dose ◽

Transplant Patients ◽

Open Label Phase ◽

Korean Study ◽

Kidney Transplant Patients ◽

Phase Iv

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Comparison of efficacy and safety between two different irbesartan, generic vs branded, in the treatment of Korean patients with mild-to-moderate hypertension: an 8-week, multicenter, randomized, open-label, Phase IV clinical study

Drug Design Development and Therapy ◽

10.2147/dddt.s172046 ◽

2018 ◽

Vol Volume 12 ◽

pp. 4217-4229

Author(s):

Seung Hwan Han ◽

Gyu Chul Oh ◽

Hyuck Moon Kwon ◽

Chang Gyu Park ◽

In Jai Kim ◽

...

Keyword(s):

Clinical Study ◽

Moderate Hypertension ◽

Efficacy And Safety ◽

Open Label ◽

Korean Patients ◽

Open Label Phase ◽

Phase Iv

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39 Results of a multicenter, open-label, phase IV study, to evaluate the early response to Bronchitol ® in patients with cystic fibrosis

Journal of Cystic Fibrosis ◽

10.1016/s1569-1993(16)30279-x ◽

2016 ◽

Vol 15 ◽

pp. S61

Author(s):

A. Thronicke ◽

C. Brandt ◽

J. Roehmel ◽

D. Staab ◽

C. Schwarz

Keyword(s):

Cystic Fibrosis ◽

Early Response ◽

Open Label ◽

Open Label Phase ◽

Phase Iv

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Effects of Collagen Hydrolysates on Human Brain Structure and Cognitive Function: A Pilot Clinical Study

Nutrients ◽

10.3390/nu12010050 ◽

2019 ◽

Vol 12 (1) ◽

pp. 50

Author(s):

Seiko Koizumi ◽

Naoki Inoue ◽

Fumihito Sugihara ◽

Michiya Igase

Keyword(s):

Cognitive Function ◽

Outcome Measures ◽

Brain Structure ◽

Short Form ◽

Gray Matter Volume ◽

Rank Correlation ◽

Secondary Outcome ◽

Open Label ◽

Associate Learning ◽

Collagen Hydrolysates

This study investigated the effects of collagen hydrolysates (CH) on language cognitive function and brain structure. In this open-label study, 5 g CH was administered once a day for 4 weeks to 30 healthy participants aged 49–63 years. The primary outcome measures were the brain healthcare quotients based on gray matter volume (GM-BHQ) and fractional anisotropy (FA-BHQ). The secondary outcome measures were changes in scores between week 0 and week 4 for word list memory (WLM) and standard verbal paired associate learning (S-PA) tests as well as changes in the physical, mental, and role/social component summary scores of the Short Form-36(SF-36) quality of life instrument. CH ingestion resulted in significant improvements in FA-BHQ (p = 0.0095), a measure of brain structure, as well in scores for the WLM (p = 0.0046) and S-PA (p = 0.0007) tests, which measure cognitive function. There were moderate correlations between the change in WLM score and the change in GM-BHQ (r = 0.4448; Spearman’s rank correlation) and between the change in S-PA score and the change in FA-BHQ (r = 0.4645). Daily ingestion of CH changed brain structure and improved language cognitive function.

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