RESEARCH/INVESTIGATIONS

CLINICAL RESEARCH PROJECTS

listed with the Food and Drug Administration (FDA) on Regulatory Form # 1572

PRINCIPAL INVESTIGATOR

This work was done at Palm Beach Research Center, 1897 Palm Beach

Lakes Blvd., Suite120, West Palm Beach, FL 33409.

12. A randomized, double blind, clinical trial to evaluate the safety and efficacy of the X for the treatment of androgenetic alopecia in females.

Principal Investigator 8/05

11. A multicenter, open-label, long-term study of X for the treatment of breakthrough pain in opioid - tolerant cancer patients.

Principal Investigator. 6/05

10. A long-term safety and efficacy study of a fixed combination of X 0.1% and Y 2.5% (X and Y topical gel) gel in subjects with acne vulgaris.

Principal Investigator. 1/05

9. A randomized, double blind, parallel group, vehicle-controlled, multiple -dose, combined phase 1/ phase 2 trial of X applied topically to the scalp of subjects with excess sebum.

Principal Investigator 1/05

8. A multicenter, open-label, long-term study of X for the treatment of breakthrough pain in opioid- tolerant cancer patients.

Principal Investigator. 1/05

7. Effect of X in combination with fixed-dose hydrochlorothiazide therapy on systolic blood pressure in hypertensive patients.

Principal Investigator. 10/04

6. An uncontrolled long-term safety trial of X gel, 1% in patients with osteoarthritis of the knee. Principal Investigator. 10/04

5. Effects of a dietary supplement on osteoarthritis & functional mobility versus glucosamine/chondroitin in a randomized, placebo controlled, double-blind trial.

Principal Investigator. 9/04

4. Evaluation of safety, tolerability, and pharmacokinetics of a 200 μg single dose of X administered buccally to opioid-tolerant cancer patients with or without oral mucositis.

Principal Investigator. 9/04

3. A 12-week, randomized, double blind, multi-center, vehicle-controlled, parallel group study to assess the efficacy and safety of the X Gel 1% for the relief of signs and symptoms in patients with osteoarthritis of the knee.

Principal Investigator. 9/04

2. A randomized, double blind, placebo controlled, parallel design, multi-site, clinical study to evaluate the bioequivalence of two X 0.75% topical gel formulations in patients with moderate to severe rosacea.

Principal Investigator. 6/04

1. A two stage, single-blind, dose-escalating study to assess the efficacy and safety of X gel applied five times per week for up to 12 weeks for the treatment of common warts in adults.

Principal Investigator. 6/04.

SUB INVESTIGATOR

This work was done at Palm Beach Research Center, 1897 Palm

Beach Lakes Blvd., Suite120, West Palm Beach, FL 33409. 

 61. A randomized, double blind, placebo controlled, parallel group, 6-week study of the effect of X aqueous spray 100 mcg qd on the hypothalamic pituitary adrenocortical (HPA) axis in pediatric subjects 2 to <12 years of age with perennial allergic rhinitis (PAR).

Sub-Investigator. 7/05.

60. A randomized, double blind, placebo-controlled, multicenter phase III study to evaluate the efficacy and safety of X 0.5 mg once daily and 0.5 mg twice daily for 12 weeks for the treatment of opioid-induced bowel dysfunction in adults taking opioid therapy for persistent non-cancer pain.

Sub- Investigator. 7/05

59. A randomized, double blind trial of X 350 mg and 250 mg tablets compared to placebo in patients with acute, painful musculoskeletal spasm of the lower back.

Sub-Investigator. 7/05

58. A randomized, double blind, placebo-controlled study of the safety and efficacy of X extended release (X-ER) tablets in the treatment of patients with postherpetic neuralgia.

Sub-Investigator. 6/05

57. A study of the efficacy and safety of 8 mg X extended-release (X ER) compared to placebo in subjects with persistent pain.

Sub-Investigator. 5/05

56. A randomized, double blind, double-dummy, multicenter, non inferiority phase III study to assess the safety and efficacy of topical 1%X ointment, applied twice daily, versus oral cephalexin, 500 mg in adults, or 12.5 mg/kg (250 mg/5 ml) in children, twice daily, in the treatment of secondarily-infected dermatoses.

Sub-Investigator. 4/05

55. A double blind, placebo-controlled evaluation of the safety and efficacy of three doses of topically applied X Gel in comparison to oral Naproxen for the treatment of the signs and symptoms of osteoarthritis of the knee.

Sub-Investigator. 4/05

54. Two identical, double blind, double-dummy, multicenter, comparative phase III studies of the safety and efficacy of topical 1% X, applied twice daily, versus oral Cephalexin, 500mg in adults, or 12.5mg/kg (250mg/5ml) in children, twice daily, in the treatment of uncomplicated secondary infected traumatic lesions.

Sub-Investigator. 4/05

53. The efficacy of X 3 mg compared to placebo in the treatment of insomnia secondary to perimenopause or menopause.

Sub-Investigator. 3/05

52. A phase III, 12-week, mult-icenter, double blind, randomized, placebo- and active comparator- controlled, parallel group study to investigate the efficacy and safety of X, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in adults with rheumatoid arthritis.

Sub-Investigator. 3/05

51. Pharmacodynamics of the 88mcg BID dose of the hydrofluoroalkane propellant formulation of inhaled X propionate following administration via the metered dose inhaler in pediatric subjects 4 to 11 years of age with asthma.

Sub-Investigator. 12/04 50.

A multi-center, standard of care-controlled study to evaluate the long-term safety of X for the treatment of chronic low back pain.

Sub-Investigator. 12/04

49. A randomized, double blind, placebo-controlled, parallel-group, 6-week study of the effect of X aqueous nasal spray 100 mcg qd on the hypothalamic pituitary adrenocortical (HPA) axis in pediatric subjects 2 to <12 years of age with perennial allergic rhinitis (PAR).

Sub-Investigator. 12/04

48. A randomized, double blind, double-dummy, multicenter, non inferiority phase III study to assess the safety and efficacy of topical 1% X ointment, applied twice daily, versus oral Cephalexin, 500mg in adults, or 12.5mg/kg (250mg/5mL) in children, twice daily, in the treatment of secondary-infected dermatoses.

Sub-Investigator. 11/04

47. A double blind, randomized, placebo-and active-controlled safety and efficacy study of X/conjugated estrogens combinations in postmenopausal women.

Sub-Investigator. 11/04.

46. A phase 1, double blind, crossover, placebo-controlled, dual injection, safety and pharmacokinetic study of X in patients with diminished DLCO and chronic obstructive pulmonary disease and/or congestive heart failure.

Sub-Investigator. 11/04

45. A randomized, double blind, placebo-controlled study evaluating X extended-release (3,900 mg/day) in the treatment of osteoarthritis of the hip or knee.

Sub-Investigator. 11/04

44. A randomized, double blind, placebo-controlled multi-center study to assess the efficacy, safety, and tolerability of X alone or in combination with Omeprazole given orally in patients suffering from symptomatic gastroesophageal reflux disease (sGERD).

Sub-Investigator. 11/04

43. A randomized, 24-week, double blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of X (15mg bid) in patients with Chronic Obstructive Pulmonary Disease (COPD).

Sub-Investigator. 10/04

42. A randomized, double blind, active-comparator-controlled, parallel-group study to evaluate the safety of X in patients with osteoarthritis or rheumatoid arthritis.

Sub-Investigator. 10/04

41. A multi-center, double blind, randomized, placebo-controlled study comparing 3 continuous oral X combinations and Y with placebo for a treatment period of 8 weeks on ambulatory and office cuff blood pressure in postmenopausal women with stage 1 or stage 2 essential hypertension.

Sub- Investigator.10/04

40. A 12 month, open-label, multicenter study to evaluate the safety of a 1.3gm oral dose of a new modified- release X acid formulation administered three times daily as needed for up to five days during the menstrual cycle in women with heavy menstrual bleeding associated with menorrhagia.

Sub- Investigator. 10/04

39. A randomized, double blind, parallel design, multi-site clinical study to compare the clinical efficacy and safety of X 0.1% cream with X 0.1% cream in pediatric patients with atopic dermatitis.

Sub- Investigator. 10/04

38. A randomized, double blind, placebo-controlled, parallel group st to evaluate the efficacy and safety of X for the treatment of acute low back pain.

Sub-Investigator. 10/04

 37. Efficacy study comparing 0.9 gm and 1.25gm of X 0.03% doses with placebo in the treatment of vasomotor symptoms and vulvar and vaginal atrophy associated with menopause.

Sub-Investigator. 9/04

36. Evaluation of safety and efficacy of of X capsules in induction of secretory conversion of endometrium and withdrawal bleeding in subjects with secondary amenorrhea.

Sub-Investigator. 9/04

35. A randomized, double blind, 6-month evaluation of the safety an efficacy of topical X in hysterectomized women with female sexual arousal disorder (FSAD).

Sub-Investigator. 8/04

34. A randomized, double blind, placebo-controlled, multicenter actual use study of the safety and tolerability of X 250 mg, and 500mg in a potential OTC population.

Sub-Investigator. 8/04

33. A multi-center, double blind, randomized, placebo-controlled study comparing 3 continuous oral X combinations and 17beta-estradiol (1mg) with placebo for a treatment period of 8 weeks on ambulatory and office cuff blood pressure in postmenopausal women with Stage 1 or Stage 2 essential hypertension.

Sub-Investigator. 8/04

32. A long-term, open-label, safety trial of X in patients with fibromyalgia.

Sub-Investigator. 7/04

31. A double blind, randomized, multicenter, two-part, parallel group, dose-ranging study of twice- daily and once-daily X in the treatment of subjects with chronic obstructive pulmonary disease.

Sub-Investigator. 6/04

30. A multicenter, randomized, double blind, placebo-controlled study of the efficacy and safety of X in patients suffering from functional dyspepsia.

Sub-Investigator. 6/04

29. A multi-center, double blind study to determine the efficacy of X tablets in relieving menopausal symptoms in estrogenized, non-hysterectomized postmenopausal woman.

Sub-Investigator. 6/04 28.

A multi-center, double blind study to determine the efficacy of X tablets in relieving menopausal symptoms in estrogenized, hysterectomized postmenopausal woman.

Sub-Investigator. 6/04

27. A multi-center, double blind study to determine the efficacy of X hs tablets in relieving menopausal symptoms in estrogenized postmenopausal woman.

Sub-Investigator. 6/04

26. A multi-center study to validate the menopausal rating scale (MRS) in a US postmenopausal population.

Sub-Investigator. 6/04

25. Long term safety and efficacy study of a fixed combination of X and Y gel in subjects with acne vulgaris.

Sub-Investigator. 3/04

24. A multicenter, randomized, double blind, active comparison study to determine the efficacy and safety of X20 or Y vs. X5 in subjects with moderate to severe low back pain.

Sub-Investigator. 3/04

23. A randomized, double blind, placebo-controlled, parallel group, multicenter study to determine the efficacy and safety of X transdermal system in subjects with moderate to severe osteoarthritis pain requiring daily treatment with opioids.

Sub-Investigator. 3/04

22. Study of X in women of different demographic characteristics and comorbidities with stress urinary incontinence: evaluation of efficacy and safety.

Sub-Investigator. 3/04

21. The efficacy of X 3 mg compared to placebo in the treatment of insomnia secondary to perimenopause or menopause.

Sub-Investigator. 3/04

20. Randomized, double blind, placebo-controlled study evaluating X extended release (3,900mg/day) in the treatment of osteoarthritis of the hip or knee.

Sub-Investigator. 3/04

19. A few weeks, randomized, double blind, placebo- and positive-controlled, parallel group, multicenter study of X in subjects with symptomatic osteoarthritis of the knee.

Sub-Investigator. 3/04

18. Efficacy and safety of X in postmenopausal women. Sub-Investigator.3/04 17. The safety, tolerability and immunogenicit of X vaccine in adults with previous smallpox vaccination.

Sub-Investigator. 3/04

16. The safety, tolerability and immunogenicity of X vaccine in adults without previous smallpox vaccination

Sub-Investigator. 3/04

15. Effects of X on bone mineral density and endometrial histology in postmenopausal women.

Sub-Investigator. 3/04

14. A phase three, parallel group, randomized, double blind, placebo controlled, multicenter trial to investigate the efficacy, tolerability, and safety of X sustained release in subjects with overactive bladder syndrome.

Sub-Investigator. 3/04

13. A randomized, double blind, placebo controlled, parallel-group, fixed-dose, multicenter study of weight-reducing and prevention of weight regain effects and safety of X in obese patients with or without co-morbidities.

Sub-Investigator. 11/01

12. A phase III, vehicle-controlled study of topical X 0.01% gel applied 2 times per week for 2 weeks each recurrence of anogenital herpes over 12 months.

Sub-Investigator. 10/01

11. A randomized, double blind, multi-center study to assess the safety of the long-term administration of X in patients with primary insomnia.

Sub-Investigator. 10/01

10. A double blind, placebo controlled, multi-center study to assess the effects of extended treatment and re-treatment in patients with plaque psoriasis enrolled in X part2; protocol X.

Sub- Investigator. 9/01

9. A randomized, double blind, placebo-controlled, parallel-group,12 week trial evaluating the efficacy and safety of the X/Y combination product 250/50mcg once daily versus X/Y Diskus combination product 100/50mcg twice daily, versus X 250/mcg once daily versus placebo in symptomatic adolescent and adult subjects with asthma that is not controlled on short acting beta-2 agonists alone.

Sub- Investigator. 9/01

8. An Evaluation of the ability of X to reduce the daily morphine requirement and limit the escalation of the daily morphine-equivale dose in order to maintain the same degree of pain control over three months in chronic pain patients with osteoarthritis.

Sub-Investigator. 8/01

7. Open-label Extension of X use in chronic pain patients.

Sub-Investigator. 8/01

6. Evaluation of the efficacy and safety of X CR (X, controlled release relative to Y (Y, controlled release) and placebo in subjects with cancer pain or chronic low back pain.

Sub-Investigator. 8/01

5. A multicenter, randomized, double blind, double dummy, placebo-controlled, complete-block crossover trial assessing the analgesic effects of X in women with primary dysmenorrhea using Y as a comparator.

Sub-Investigator. 8/01

4. A study of the safety and efficacy of X laxative for the treatment of constipation in users of non-prescription laxatives.

Sub-Investigator. 8/01

3. A multi-center, randomized, double blind, parallel group, placebo-controlled study to investigate the long-term effects of X/Y propionate 50/500ug bid and X 500ug bid, all delivered via the Discus/Accuhaler TM inhaler, on the survival of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment.

Sub-Investigator. 8/01

2. An open-label pharmacokinetic study of X in Patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, S. pyogenes tonsillitis/pharyngitis, community acquired pneumonia or uncomplicated skin and skin structure infection.

Sub-Investigator. 8/01

1.Vehicle-controlled, double-blind study to assess the safety and efficacy of X 5% cream applied once daily, two days per week for the treatment of actinic keratoses on the head.

Sub-Investigator. 8/01

OTHER CLINICAL RESEARCH

at Jackson Memorial Trauma service, Dept. of Surgery, University of Miami School of Medicine

A randomized prospective study investigating the effectiveness of a biofragmentable anastomosis ring (BAR) versus staples or sutures in colostomy closures.

Trauma service, Dept. of Surgery, University of Miami School of Medicine. Trauma Center, Study done in collaboration with Patricia Byers, M.D., Trauma Services Chief. Sub-Investigator. 1991

Nursing notes study in the surgical intensive care unit (SICU) at Jackson Memorial Hospital, the teaching hospital for the University of Miami School of Medicine.

This study laid the foundation for the first computer system used in the SICU at Jackson Memorial Hospital. Project done in collaboration with Joseph M. Civetta, M.D., Professor of Surgery, Anesthesia, Medicine, and Pathology; Director of all Intensive Care Medicine at Jackson Memorial Hospital in Miami, FL. 1975.

Research Project: Hepatic coma and the sudden death of the alcoholic. Project done in collaboration with Dade County Medical Examiner, Joseph H. Davis, M.D. 1975.

CLINICAL DERMATOLOGY RESEARCH FELLOWSHIP,

University of Miami, School of Medicine, Department of Cutaneous Surgery:

Clinical Signed Ferndale Labs to a $21,000 contract to study hypothesis by Sawada and Sone that hydration and occlusion have anti-keloid effects.

Principal Investigator and first author. 2/94

Wrote study protocol and received IRB approval (Univ. of Miami School of Medicine).

Conducted seminal research using Graftskin (TM), a living skin equivalent, whereby multiple fungal infections were induced then treated with antifungal agents and topical steroids.

Principal Investigator and co- author. 2/94

Wrote study protocol and received IRB approval (Univ. of Miami School of Medicine) to study the effects of pentoxifylline applied to surgical excision sites. Purpose: to determine if topical application of pentoxifylline postoperatively to surgical excision sites effects scar formation, and to determine if topical pentoxifylline improves cosmetic outcome of the scar after surgical revision.

Principal Investigator. 2/94

Received IRB approval (Univ. of Miami School of Medicine) for study protocol to study X cream (X 1% cream) in a double-blind, placebo controlled trial for the treatment of cutaneous candidiasis.

Principal Investigator. 2/94

Wrote study protocol and received IRB approval (University of Miami School of Medicine) A double blind, placebo controlled trial of compound X in the treatment of keloids.

Principal Investigator 3/95

Received IRB approval (Univ. of Miami School of Medicine). The efficacy and safety of X 0.1% with Y cream 0.2% in the treatment of moderate to severe atopic dermatitis.

Principal Investigator. 2/94

Reviewed extensive protocol and prepared cost analysis for a phase III, double-blind, placebo controlled trial for X IL-2, for the treatment of cutaneous T-cell lymphoma (CTCL). Analysis revealed inadequate financial support to cover projected and potential costs and was not undertaken.

Principal Investigator. 2/95