Concomitant Therapy Sample Clauses
A Concomitant Therapy clause defines the rules and restrictions regarding the use of additional medications or treatments by participants during a clinical trial. It typically outlines which therapies are permitted, prohibited, or require prior approval while the study drug is being administered. For example, participants may be allowed to continue certain standard treatments but must avoid others that could interfere with the study results. The core function of this clause is to ensure the integrity of the trial data by minimizing confounding factors and maintaining participant safety.
Concomitant Therapy. Concomitant medications are any prescription or over-the-counter preparations used by subjects during participation in the trial. Use of concomitant medications will be recorded on the Concomitant Medications case report form (CRF) beginning at the Screening Visit until the Week 16/Early Termination visit. The dose and dosing regimen of all prescription and non-prescription therapies and medications, including herbs, vitamins, or other nutritional supplements administered will be documented. Standardized home therapy program including Achilles tendon and plantar fascia stretching exercises and night splints will also be recorded throughout the study.
Concomitant Therapy. Any medication or vaccine (including over-the-counter or prescription medicines, vitamins, and/or herbal supplements) or other specific categories of interest) that the participant is receiving from 14 days prior to study enrollment (Day -7) until the end of study visit must be recorded along with: • Reason for use • Dates of administration including start and end dates • Dosage information including dose and frequency The Medical Monitor should be contacted if there are any questions regarding concomitant and/or prior therapy.
Concomitant Therapy. This study is a comparison of standard care plus levosimendan to standard care plus placebo for the treatment of subjects in the immediate perioperative period. All patients should receive standard evidenced based therapies as recommended in local clinical practice guidelines. The patient’s regular per oral concomitant treatments (diuretics, digitalis, ACE inhibitors, nitrates, beta-blockers, and other medications e.g. antibiotics and analgesics) can be administered according to the investigator’s clinical judgment, All subjects may receive additional standard of care medications including inotropes, pressors, vasopressin, antiarrhythmics, diuretics, nitrates, and nitric oxide as needed. Due to the potentially hypotensive effects of the study drug, the concomitant use of vasodilatory active drugs should be used with caution as per the following guidance.
Concomitant Therapy. Patients can be on stable ≤ 1 preventive medication and any number of abortive migraine medications for at least 90 days prior to Screening. Up to approximately 30% of the patients randomized into the study can be on 1 preventative medication. Once this category is filled, only patients who are not on any preventative medications can be randomized into the study. From study start, sites should enroll patients into both categories in parallel until informed otherwise. All treatments, other than the study drug, thought to have preventive efficacy in migraine should not be started or discontinued during the entire study period. Other prescription or over the counter medication not specifically excluded by entry criteria may be continued during the study, provided that the patient has been on this medication for at least 30 days at a stable dose prior to the date of randomization, and usage is expected to remain stable throughout the study. In addition, certain other medications will also be prohibited and may require washout, or exclusion of the patient if washout is not appropriate. Chronic use of NSAIDs daily is not allowed, therefore those on daily NSAIDs necessary for treatment of other medical conditions (e.g., arthritis), should not be enrolled. NSAIDs may be used as needed for abortive migraine treatment only if they are part of the patient’s typical migraine/headache abortive treatment regimen. Other use of NSAIDs is allowed as needed for other acute pain syndromes, but daily use is not allowed. Use of ibuprofen for such PRN use of NSAIDs is preferred over longer acting NSAIDs, e.g., naproxen and celecoxib. Concomitant medications or other treatments must be recorded in the patient’s medical record and case report form along with the dose and dates of treatment.
Concomitant Therapy. Concomitant medications will be summarized for the safety population.
Concomitant Therapy. Throughout the study, investigators may prescribe any concomitant medications or treatments deemed necessary to provide adequate supportive care except for those listed in Section 6.9. Any medication including over the counter or prescription medicines, vitamins and/or herbal supplements that the participant is receiving at the time of enrollment / randomization or receives during the study through to week 24 must be recorded in the eCRF along with reason for use, dates of administration (including start and end dates) and dosage information (e.g. dose).
Concomitant Therapy. Patients enrolled in this trial may receive any conventional stroke treatment at the discretion of their attending physicians. Patients may not be enrolled in another therapeutic clinical trial until after exit from FAST-MAG after the 90 day visit. Patients may not be treated with other experimental stroke therapies. Treatment with tissue plasminogen activator within 3 hours of symptom onset, after exclusion of intracranial hemorrhage, is encouraged in patients who meet thrombolytic treatment criteria outlined in national consensus guidelines. Since in vitro compatibility has not been tested, a separate IV line should be employed if tissue plasminogen activator and the FAST- MAG trial solution are being infused simultaneously. Prespecified secondary analyses will examine the effect of study treatment in ischemic stroke patients treated with and treated without thrombolytic therapy. Evidence for the safety of concomitant magnesium sulfate and fibrinolytic therapy comes from the absence of adverse interaction among more than 41,000 MI patients receiving both magnesium sulfate and fibrinolytic agents in large cardiac trials, as reviewed above. [1,2] Additionally, the US manufacturer of TPA has on file no reports of adverse interactions between magnesium sulfate and tissue plasminogen activator in preclinical or clinical datasets (personal communication, ▇▇▇▇▇▇▇ ▇▇▇▇▇, M.D, Genentech, 9/02) and the FDA Medwatch program has not logged any reports of adverse magnesium-TPA interactions (FDA FOIA inquiry, 9/02).
Concomitant Therapy. 6.3.1 Cyclosporin A
6.3.2 Intrathecal Methotrexate and Glucocorticoids
6.3.3 Other possible concomitant therapies
6.3.4 Not allowed concomitant therapies
Concomitant Therapy. The use of any concomitant medication, prescription or over-the-counter, is to be recorded on the subject’s electronic case report form (eCRF) at each visit, along with the reason the medication is taken, the dates of administration, and the dose.