CLINICAL TRIALS PROFILE FOR ACETYLCHOLINE CHLORIDE
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All Clinical Trials for acetylcholine chloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00711087 ↗ | Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344) | Terminated | U.S. Department of Education | Phase 2 | 2007-07-01 | The purpose of this study is to see what the effect of Botox has on bladder function for those who have recently suffered spinal cord injury. We also will study bladder tissue levels of NGF (nerve growth factor) that can tell us how the nerves to the bladder are healing after injury. Consenting male and female cervical and high thoracic (T10 and above) SCI patients will be identified within the first 6-7 weeks after SCI and randomized to two external urethral sphincter injection groups. Each group will be injected within 8 weeks after SCI (Day 0) and 3 months later (Day 90). The injection paradigm will consist of: Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90; Group 2-sham saline injections on both Day 0 and Day 90. Injections will be performed under local anesthesia using standard flexible cystoscopic equipment. Use of placebo is justified because: 1. there have been documentation of nerve desensitization with dry needling (i.e. acupuncture) and wet needling (i.e. saline)--therefore, to truly demonstrate benefit of Botox over just the needle insertion into the sphincter muscle or injection of the diluent saline, a sham saline injection group is included, 2. the injection procedure itself is minimally invasive and not expected to result in any complications. Subjects who qualify and have signed the informed consent document will be randomized into two groups, those receiving the BTX-A and those receiving placebo. Blinding will be performed by the TIRR pharmacy department who will provide Botox and placebo in identical syringes so that the treating staff will be blinded. Pharmacists will ensure patients receive the same agent at the time of the second injection. Unblinding will occur at the end of the study or if complications necessitate breaking of the code. Both groups will undergo urodynamic testing to document before and after treatment data. Bladder biopsies will be taken prior to treatment in both groups that will be analyzed for nerve growth factor. Three day voiding diaries will be kept and reviewed with the study coordinator at the follow up visits. Quality of life questionnaires will be completed at each follow up visit. The treatments will take place on Day 0 and Day 90. Follow up visits will occur at Day 120, 16 month, and 28 months. |
| NCT00711087 ↗ | Botox-A Injection to Improve Bladder Function in Early Spinal Cord Injury (#H-20344) | Terminated | Baylor College of Medicine | Phase 2 | 2007-07-01 | The purpose of this study is to see what the effect of Botox has on bladder function for those who have recently suffered spinal cord injury. We also will study bladder tissue levels of NGF (nerve growth factor) that can tell us how the nerves to the bladder are healing after injury. Consenting male and female cervical and high thoracic (T10 and above) SCI patients will be identified within the first 6-7 weeks after SCI and randomized to two external urethral sphincter injection groups. Each group will be injected within 8 weeks after SCI (Day 0) and 3 months later (Day 90). The injection paradigm will consist of: Group 1-100 units of BTX-A (Botox®, Allergan Inc., Irvine, CA) on Day 0 and 100 units of BTX-A on Day 90; Group 2-sham saline injections on both Day 0 and Day 90. Injections will be performed under local anesthesia using standard flexible cystoscopic equipment. Use of placebo is justified because: 1. there have been documentation of nerve desensitization with dry needling (i.e. acupuncture) and wet needling (i.e. saline)--therefore, to truly demonstrate benefit of Botox over just the needle insertion into the sphincter muscle or injection of the diluent saline, a sham saline injection group is included, 2. the injection procedure itself is minimally invasive and not expected to result in any complications. Subjects who qualify and have signed the informed consent document will be randomized into two groups, those receiving the BTX-A and those receiving placebo. Blinding will be performed by the TIRR pharmacy department who will provide Botox and placebo in identical syringes so that the treating staff will be blinded. Pharmacists will ensure patients receive the same agent at the time of the second injection. Unblinding will occur at the end of the study or if complications necessitate breaking of the code. Both groups will undergo urodynamic testing to document before and after treatment data. Bladder biopsies will be taken prior to treatment in both groups that will be analyzed for nerve growth factor. Three day voiding diaries will be kept and reviewed with the study coordinator at the follow up visits. Quality of life questionnaires will be completed at each follow up visit. The treatments will take place on Day 0 and Day 90. Follow up visits will occur at Day 120, 16 month, and 28 months. |
| NCT01387425 ↗ | Efficacy And Safety Of Smoking Cessation With Varenicline Tartrate In Diabetic Smokers: (DIASMOKE) | Completed | Universita degli Studi di Catania | N/A | 2011-06-01 | Objectives This protocol is intended to provide information regarding the efficacy and safety of the nicotine partial agonist varenicline tartrate, at a dose of 1 mg twice daily, for smoking cessation in diabetic subjects who smoke. Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at the end of the study will also be examined Study Population The study will enroll 150 type 2 diabetic patients (≤ 75 years) who are regular smokers (≥10 cigs/day) and motivated to stop smoking in each of 2 treatment arms (active drug and placebo) Study Design The study is a double-blind, placebo-controlled, randomized clinical trial designed to assess the efficacy and safety of varenicline 1 mg BID in comparison to placebo for smoking cessation. The duration of active treatment will be 12 weeks and subjects will be followed in the nontreatment phase for an additional 12 weeks. This clinical study has an optional research component to prolong the follow up in the nontreatment phase for a full year. Predictors of abstinence at the end of the study will also be examined Study Endpoints Primary Endpoint: Success rates at week 24 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate since last visit. Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on the study visit at week 24 Co-primary endpoint: Success rates at week 12 in the varenicline vs placebo group. Success rates will be defined as Continuous Quit Rate for Weeks 8 to 12 of treatment. Subjects will be classified as responders if they are able to maintain complete abstinence from cigarette smoking in each of the last four study visits (week 9, week 10, week 11, and week 12) with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last four study visits (week 9, week 10, week 11, and week 12) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Secondary Endpoint: Success rates at week 52 in the varenicline vs placebo group. Success rates will be defined as the Continuous Quit Rate throughout the last three visits (week 24, week 36, and week 44). Subjects will be classified as responders if they are able to maintain abstinence from cigarette smoking during this period of time with end-expiratory exhaled CO measurements ≤ 10 ppm. This measure will be obtained through reports of cigarette use by means of the Nicotine Use Inventory during the last three study visits (week 24, week 36 and week 44) confirmed by a measurement of an end-expiratory exhaled carbon monoxide concentration that is ≤ 10 ppm on each study visit Additional Measures: Given that a better understanding of predictors of smoking cessation can be useful in identifying potential quitters and likely relapsers and that little is known about these predictors in diabetics, the role of different predictors of abstinence at week 24 and at week 52 will also be examined |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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