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Trial record 14 of 62 for:    dry mouth | NIH

Pilocarpine in Preventing Mucositis and Dry Mouth in Patients Receiving Radiation Therapy for Head and Neck Cancer

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ClinicalTrials.gov Identifier: NCT00003139
Recruitment Status : Completed
First Posted : September 6, 2004
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief Summary:

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as pilocarpine may protect normal cells from the side effects of radiation therapy. It is not yet known if pilocarpine may be effective in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.

PURPOSE: Randomized, double-blinded, phase III trial to study the effectiveness of pilocarpine in preventing mucositis and dry mouth in patients receiving radiation therapy for head and neck cancer.


Condition or disease Intervention/treatment Phase
Head and Neck Cancer Oral Complications Drug: pilocarpine hydrochloride Other: Placebo Phase 3

Detailed Description:

OBJECTIVES: I. Determine whether prophylactic use of pilocarpine can shelter unstimulated and stimulated whole salivary flow in patients with head and neck cancer. II. Determine whether prophylactic use of pilocarpine can moderate xerostomia in these patients. III. Determine whether prophylactic use of pilocarpine can reduce the grade and duration of radiation induced mucositis in these patients. IV. Evaluate quality of life outcomes between patients receiving pilocarpine versus placebo. V. Evaluate the impact of xerostomia on patients receiving irradiation to the head and neck.

OUTLINE: This is a randomized, double blind study. Patients receive a central axis midplane dose of radiotherapy five days per week over 6 to 7 weeks. Oral pilocarpine or placebo is administered beginning 3 days prior to radiotherapy, one tablet four times per day for three months. A tablet will be taken 45-60 minutes before radiotherapy. After three months, and after a 3-4 day rest period, all patients receive non blinded pilocarpine for an additional three month period. Patients are followed at weeks 4, 13, and 26 after the start of radiotherapy.

PROJECTED ACCRUAL: A total of 244 patients will be accrued (122 per treatment arm).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 249 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: A Phase III Study to Test the Efficacy of the Prophylactic Use of Oral Pilocarpine to Reduce Hyposalivation and Mucositis Associated With Curative Radiation Therapy in Head and Neck Cancer Patients
Study Start Date : March 1998
Actual Primary Completion Date : January 2001
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pilocarpine hydrocloride
5mg pilocarpine hydrochloride tablets commencing 3 days prior to irradiation
Drug: pilocarpine hydrochloride
5mg pilocarpine hydrochloride tablets

Placebo Comparator: Placebo
Placebo tablets commencing 3 days prior to irradiation
Other: Placebo



Primary Outcome Measures :
  1. Acute salivary gland toxicity [ Time Frame: From the start of treatment to 13 weeks ]

Secondary Outcome Measures :
  1. Acute mucositis in the pharynx, palate, tongue, or buccal [ Time Frame: From the start of treatment to 13 weeks ]
  2. Quality of life as measured by the University of Washington Head and Neck Symptom questionnaire [ Time Frame: Pretreatment to 26 weeks from the start of treatment ]
  3. Effects of continuing pilocarpine out to 6 months from the start of treatment [ Time Frame: From the start of treatment to 26 weeks ]


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven oral cavity and/or oropharyngeal squamous cell carcinoma Radiation volume to encompass at least 50% of parotid glands and have at least 50 Gy delivered to that volume via external beam No salivary gland malignancies or diseases

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky 60-100% Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Effective contraceptive method must be used during study No pilocarpine allergy

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to head or neck Surgery: Not specified Other: No concurrent adrenergic antagonists, cholinergic drugs, anti-cholinergics, or tricyclics


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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003139


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United States, Alabama
Veterans Affairs Medical Center - Birmingham
Birmingham, Alabama, United States, 35233
University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294
Huntsville Hospital System
Huntsville, Alabama, United States, 35801
Urology Associates - Mobile AL
Mobile, Alabama, United States, 36640
MBCCOP - University of South Alabama
Mobile, Alabama, United States, 36688
Alabama Oncology, LLC
Montgomery, Alabama, United States, 36106-2801
Radiation Oncology Associates of West Alabama
Tuscallosa, Alabama, United States, 35401
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Providence Cancer Therapy Center
Anchorage, Alaska, United States, 99508
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Arizona Cancer Center
Tucson, Arizona, United States, 85724
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Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States, 91505
Mount Diablo Medical Center
Concord, California, United States, 94524-4110
Beckman Research Institute, City of Hope
Duarte, California, United States, 91010
California Cancer Center
Fresno, California, United States, 93720
Saint Agnes Cancer Center
Fresno, California, United States, 93720
Glendale Memorial Hospital and Health Center
Glendale, California, United States, 91204
Sutter Health Western Division Cancer Research Group
Greenbrae, California, United States, 94904
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
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Long Beach, California, United States, 90822
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Los Angeles, California, United States, 90027
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033-0800
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
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Martinez, California, United States, 94553
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Oakland, California, United States, 94609-3305
Cancer Care Center
Pomona, California, United States, 91767
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Redding, California, United States, 96099-6009
Radiation Oncology Center - Sacramento
Sacramento, California, United States, 95816
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
Santa Cruz Radiation Oncology Medical Group, Inc.
Santa Cruz, California, United States, 95065
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Santa Rosa, California, United States, 95403
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Stanford, California, United States, 94305
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Travis Air Force Base, California, United States, 94535
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Washington, District of Columbia, United States, 20307-5000
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Lykes Center for Radiation Therapy
Clearwater, Florida, United States, 33757-0210
Halifax Medical Center
Daytona Beach, Florida, United States, 32114
Radiation Therapy Associates - Fort Myers
Fort Myers, Florida, United States, 33901
University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0296
Health First Holmes Regional Medical Center
Melbourne, Florida, United States, 32901
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Miami Beach, Florida, United States, 33140
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Miami, Florida, United States, 33176-2197
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Mary Bird Perkins Cancer Center
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Baltimore, Maryland, United States, 21237
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Baltimore, Maryland, United States, 21287
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Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
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Boston, Massachusetts, United States, 02215
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CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
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Methodist Cancer Center - Omaha
Omaha, Nebraska, United States, 68114
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Omaha, Nebraska, United States, 68131
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CCOP - Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, United States, 89106
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Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756
Elliot Regional Cancer Center
Manchester, New Hampshire, United States, 03103
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Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
John F. Kennedy Medical Center
Edison, New Jersey, United States, 08818
Elizabeth General Medical Center - West
Elizabeth, New Jersey, United States, 07201
South Jersey Hospital - Millville
Millville, New Jersey, United States, 08332
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, United States, 08060
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Toms River, New Jersey, United States, 08755
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Trenton, New Jersey, United States, 08629
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Saint Joseph Medical Center
Albuquerque, New Mexico, United States, 87102
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Cancer Center of Albany Medical Center
Albany, New York, United States, 12208
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Albany, New York, United States, 12208
Albert Einstein Comprehensive Cancer Center
Bronx, New York, United States, 10461
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, United States, 11203
New York Methodist Hospital
Brooklyn, New York, United States, 11215-3609
CCOP - North Shore University Hospital
Manhasset, New York, United States, 11030
Kaplan Cancer Center
New York, New York, United States, 10016
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Champlain Valley Physicians Hospital Medical Center
Plattsburgh, New York, United States, 12901
Vassar Brothers Hospital
Poughkeepsie, New York, United States, 12601
Genesee Hospital - Rochester
Rochester, New York, United States, 14607
University of Rochester Cancer Center
Rochester, New York, United States, 14642
New York Medical College
Valhalla, New York, United States, 10595
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Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
East Carolina University School of Medicine
Greenville, North Carolina, United States, 27858-4354
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Winston-Salem, North Carolina, United States, 27104-4241
Comprehensive Cancer Center of Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, United States, 27157-1082
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Meritcare Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
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Minot, North Dakota, United States, 58701
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Akron General Medical Center
Akron, Ohio, United States, 44302
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Akron, Ohio, United States, 44309
Christ Hospital
Cincinnati, Ohio, United States, 45219
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
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Columbus, Ohio, United States, 43206
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
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Dayton, Ohio, United States, 45428
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Kettering, Ohio, United States, 45429
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Toledo, Ohio, United States, 43623-3456
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St. John Medical Center
Tulsa, Oklahoma, United States, 74104
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Samaritan Regional Cancer Center
Corvallis, Oregon, United States, 97339
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Portland, Oregon, United States, 97213
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Penn State Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Mercy Catholic Medical Center, Mercy Fitzgerald Divison
Darby, Pennsylvania, United States, 19023
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, United States, 19026
Penn State Geisinger Cancer Center
Hershey, Pennsylvania, United States, 17033
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Philadelphia, Pennsylvania, United States, 19102-1192
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Philadelphia, Pennsylvania, United States, 19104
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Philadelphia, Pennsylvania, United States, 19104
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107
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Philadelphia, Pennsylvania, United States, 19111
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Philadelphia, Pennsylvania, United States, 19141
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Reading, Pennsylvania, United States, 19612-6052
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Charleston, South Carolina, United States, 29425-0721
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Greenville, South Carolina, United States, 29615
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Jackson, Tennessee, United States, 38301
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Pasadena, Texas, United States, 77504
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Saint George, Utah, United States, 84770
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Salt Lake City, Utah, United States, 84143
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Bennington, Vermont, United States, 05201
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Rutland, Vermont, United States, 05701
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White River Junction, Vermont, United States, 05009
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Martha Jefferson Hospital
Charlottesville, Virginia, United States, 22901
Cancer Center, University of Virginia HSC
Charlottesville, Virginia, United States, 22908
Virginia Baptist Hospital
Lynchburg, Virginia, United States, 24503
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
Massey Cancer Center
Richmond, Virginia, United States, 23298-0037
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Swedish Hospital Tumor Institute
Seattle, Washington, United States, 98104
Virginia Mason Medical Center
Seattle, Washington, United States, 98111
Deaconess Medical Center
Spokane, Washington, United States, 99210-0248
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Yakima, Washington, United States, 98902
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Schiffler Oncology Center
Wheeling, West Virginia, United States, 26003
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St. Vincent Hospital
Green Bay, Wisconsin, United States, 54307-3508
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, United States, 54601
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, United States, 53705
Southern Wisconsin Radiotherapy Center
Madison, Wisconsin, United States, 53713
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Community Memorial Hospital
Menomonee Falls, Wisconsin, United States, 53051
St. Joseph's Hospital
Milwaukee, Wisconsin, United States, 53210
Columbia Hospital
Milwaukee, Wisconsin, United States, 53211
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, United States, 53295
Southeastern Wisconsin Regional Cancer Center
Racine, Wisconsin, United States, 53405
Canada, Alberta
Tom Baker Cancer Center - Calgary
Calgary, Alberta, Canada, T2N 4N2
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
British Columbia Cancer Agency - Vancouver Island Cancer Centre
Victoria, British Columbia, Canada, V8R 1J8
Canada, New Brunswick
Doctor Leon Richard Oncology Centre
Moncton, New Brunswick, Canada, E1C 8X3
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6
Ottawa Regional Cancer Centre - Civic Campus
Ottawa, Ontario, Canada, K1Y 4K7
Northeastern Ontario Regional Cancer Centre, Sudbury
Sudbury, Ontario, Canada, P3E 5J1
Northwestern Ontario Regional Cancer Centre, Thunder Bay
Thunder Bay, Ontario, Canada, P7A 7T1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University Department of Oncology
Montreal, Quebec, Canada, H2W 1S6
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2W-W1T8
Canada, Saskatchewan
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada, S7N 4H4
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Francis G. LeVeque, DDS Barbara Ann Karmanos Cancer Institute

Publications of Results:
Fisher JJ, Scott CB, Scarantino CW, et al.: Phase III quality of life (Qol) study: reduction in hyposalivation does not improve Qol for head and neck (H&N) cancer patients post radiation therapy (P-RT). RTOG 9709. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1423, 2002.
Scarantino CW, Leveque FG, Scott CB, et al.: A phase III study of concomitant oral pilocarpine to reduce hypo-salivation and mucositis associated with curative radiation therapy (RT) in the head and neck (H&N) cancer patients. RTOG 9709. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-897, 225a, 2001.
Scarantino CW, Leveque F, Scott C, et al.: A phase III study on the concurrent use of oral pilocarpine to reduce hyposalivation and mucositis associated with radiation therapy in head and neck cancer patients: final results of RTOG 97-09. [Abstract] Int J Radiat Oncol Biol Phys 51(3 suppl 1): A-157, 85-86, 2001.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003139     History of Changes
Other Study ID Numbers: RTOG-9709
CDR0000065912
NCI-P97-0121
First Posted: September 6, 2004    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Radiation Therapy Oncology Group:
oral complications
lip and oral cavity squamous cell carcinoma
oropharyngeal squamous cell carcinoma

Additional relevant MeSH terms:
Mouth Diseases
Head and Neck Neoplasms
Mucositis
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomatognathic Diseases
Pilocarpine
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action